View source for Information Notice 1997-65, Failures of High-Dose-Rate (HDR) Remote Afterloading Device Source Guide Tubes, Catheters, and Applicators

{{Adams
| number = ML031050140
| issue date = 08/15/1997
| title = Failures of High-Dose-Rate (HDR) Remote Afterloading Device Source Guide Tubes, Catheters, and Applicators
| author name = Cool D A
| author affiliation = NRC/NMSS/IMNS
| addressee name = 
| addressee affiliation = 
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| license number = 
| contact person = 
| document report number = IN-97-065, NUDOCS 9708110173
| document type = NRC Information Notice
| page count = 11
| revision = 0
}}
{{#Wiki_filter:UNITED STATESNUCLEAR REGULATORY COMMISSIONOFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDSWASHINGTON, D.C. 20555August 15, 1997NRC INFORMATION NOTICE 97-65: FAILURES OF HIGH-DOSE-RATE (HDR)REMOTE AFTERLOADING DEVICE SOURCEGUIDE TUBES, CATHETERS, ANDAPPLICATORS

==Addressees==
All high-dose-rate (HDR) remote afterloader licensees.purposeThe U.S. Nuclear Regulatory Commission (NRC) is issuing this information notice to alertaddressees to reports of failures in source guide tubes, catheters, and applicators used withHDR devices supplied by the three major U. S. vendors of these devices. Licensees should beaware of the potential for similar failures during the course of patient treatments and thepossible risk(s) associated with the loss of containment of a HDR source. It is expected thatrecipients will review the information for applicability to their facilities and consider actions,as appropriate, to avoid similar problems. However, suggestions contained in this informationnotice are not NRC requirements; therefore, no specific action nor written response is required.

==Description of Circumstances==
During the last several years, NRC has received reports of failures of HDR source guide tubes,catheters, and applicators used to place and contain the HDR source during patient treatments.Most recently, the Food and Drug Administration (FDA) provided NRC with its inspectionfindings documenting such failures for Nucletron Corporation devices. A brief summary of theknown failures follows:1. The FDA's March 1997, inspection findings at Nucletron Corporation includedreported failures of Ring I/U tube applicators, Flexiguide cone catheters breakinginside patients, problems with numbers wearing off transfer tubes, catheterlength variations, and one reported problem with an esophagal catheter.2. A similar FDA inspection of Omnitron Corporation, in November 1993, foundnumerous reported failures with their Flexineedle applicators, and GYN andstandard catheters. Reports indicate that components of the Flexineedleapplicators have separated inside patients and, in some cases, have not beenretrieved.9708qT11 rot NOTI1 l1 -D11 11151 IN 97-65August 15, 1997 . In 1993, an NRC licensee reported that a Gamma Med II source guide tubebroke away from a vaginal cylinder. This resulted in the HDR source beingdriven onto the table, rather than into the vaginal cylinder. A subsequent checkfor defects by the licensee of all guide tubes and applicators, revealed that sixbronchial, one tandem, and two intracavity tubes were defective.The causes for these defects in the applicators, guide tubes, and catheters have been variouslyascribed to design defects, errors in manufacturing, or improper sterilization procedures. Whileactions on the part of manufacturers have likely resulted in-correction of most of the identifiedproblems, licensees performing HDR brachytherapy treatments should be aware of thepotential for failure of HDR device accessories.DiscussionGiven that HDR device applicators, guide tubes, and catheters can fail suddenly and in anunexpected manner, it is important that users of these components take appropriate pre-cautions, to the extent practicable, to protect their patients from injuries. NRC is particularlyconcerned about the possibility of both patients and health care providers receiving significantradiation exposures. The potential for significant radiation exposure could be reduced iflicensees were aware of the possibility of such failures and, as a direct result, were prepared tosafely and expeditiously handle the resulting emergency situation.In recognition of the hazards associated with an event where a HDR source either becomesstuck or detached during a patient treatment, NRC requested, in NRC Bulletin 93-01, thatlicensees commit to providing written emergency procedures for responding to either ofthese potential emergency situations. This item was subsequently incorporated in Policyand Guidance Directive FC 86-4 (Rev. 1) which provided NRC license reviewers with guid-ance for licensing HDR device applications. Some licensees responded to this request bystating that such an event is improbable, since the source is always contained within the guidetube and/or applicator of the device, thus, negating any need for establishing the requestedemergency procedures. Knowing that there have been multiple reported failures of thiscontainment system, licensees may wish to reconsider the necessity of having preplannedemergency surgical procedures as an integral part of their emergency response procedures forHDR patient treatments.Although the probability of a failure of the containment system simultaneous to the sourcesticking or becoming detached would be expected to be very small, the failure of a con-tainment system could, for example, increase the probability that the HDR source wouldbecome stuck or detached by obstructing the path of the source, or a HDR source that becamestuck or detached within the source transportlcontainment system could stress the containmentsystem, resulting in breaching the containment. Thus, a failure of either the containmentsystem or the source could easily increase the probability for the failure of the othe IN 97-65August 15, 1997 The FDA has the primary responsibility for regulating the design and manufacture of these HDRguide tubes, applicators, and catheters. Therefore, it is important that the FDA be notified ofany failures or defects with such devices, so that any problems, with a potential for patientinjury, can be corrected.Licensees should be aware that medical device user facilities are now subject to mandatoryFDA adverse event reporting requirements for medical devices. Information concerning FDA'smandatory reporting requirements can be obtained by contacting the Center for Devices andRadiological Health, Office of Surveillance and Biometrics, Division of Surveillance Systems, at301-594-2735. Since the FDA mandatory reporting requirements may not be applicable to allmedical device events, FDA also depends on information voluntarily provided by device usersbecause they are often the first to recognize medical device-related hazards. Any concernsthat licensees may have pertaining to the safety or quality problems associated with medicaldevices can be voluntarily reported to the FDA by calling MedWatch at 1-800-FDA-1088.Voluntary reports can be submitted anonymously.This information notice requires no specific action nor written response. If you have anyquestions about the information in this notice, please contact the technical contact listed belowor the appropriate NRC regional office.Donald A. Cool, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyard SafeguardsTechnical contact: Robert L. Ayres, NMSS301-415-5746E-mail: rxal@nrc.gov

===Attachments:===
ALe ALAZ 4t1. List of Recently Issued NMSS Information Notices 72. List of Recently Issued NRC Information Notices s-_K-,Attachment 1IN 97-65August 15, 1997Page 1 of ILIST OF RECENTLY ISSUEDNMSS INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to97-64Potential ProblemsAssociated with Lossof Electrical Powerin Certain TeletherapyUnits08/13/97All U.S. Nuclear RegulatoryCommission medical tele-therapy licensees97-6197-5897-5797-5697-55U.S. Department ofHealth and HumanServices Letter, toMedicaland manufacturers/distri-facturers, on theYear 2000 ProblemMechanical Integrity ofIn-Situ Leach InjectionWells and PipingLeak Testing of PackagingUsed in the Transport ofRadioactive MaterialPossession Limits forSpecial Nuclear Materialat the Envirocare ofUtah Low-Level RadioactiveWaste Disposal FacilityCalculation of SurfaceActivity for ContaminatedEquipment and Materials08/06/97Device Manu-07/31/9707/30/9707/28/9707/23/97All U.S. Nuclear RegulatoryCommission medicallicensees, veterinarians,butors of medical devicesHolders of and Applicantsfor Licenses for In-SituLeach FacilitiesSuppliers and users ofpackaging for the trans-portation of radioactivematerial required to per-form packaging leak testsAll licensees authorizedto possess special nuclearmaterialAll Uranium RecoveryLicensees 
~~K>Attachment 2IN 97-66August 15, 1997 LIST OF RECENTLY ISSUEDNRC INFORMATION NOTICESInformation Date ofNotice No. Subject Issuance Issued to97-6497-6397-6297-61Potential ProblemsAssociated with Lossof Electrical Powerin Certain TeletherapyUnitsStatus of NRC Staff'sReview of BWRVIP-05Unrecognized ReactivityAddition During PlantShutdownU.S. Department ofHealth and HumanServices Letter, toMedical Device Manu-facturers, on theYear 2000 ProblemIncorrect UnreviewedSafety Question Deter-mination Related toEmergency Core CoolingSystem Swapover fromthe Injection Mode tothe Recirculation ModeFire Endurance TestResults of VersawrapFire Barriers08/13/9708/07/9708/06/9708/06/9708/01/9708/01/97All U.S. Nuclear RegulatoryCommission medical tele-therapy licenseesAll holders of OLs or CPsfor boiling water reactorsAll holders of OLs or CPsfor nuclear power reactorsAll U.S. Nuclear RegulatoryCommission medical licensees,veterinarians, and manu-facturers/distributors ofmedical devicesAll holders of OLs or CPsfor pressurized-waterreactorsAll holders of OLs or CPsfor nuclear power reactors97-6097-59OL = Operating LicenseCP = Construction Permit IN 97-65August 15, 1997 The FDA has the primary responsibility for regulating the design and manufacture of these HDRguide tubes, applicators, and catheters. Therefore, it is important that the FDA be notified ofany failures or defects with such devices, so that any problems, with a potential for patientinjury, can be corrected.Licensees should be aware that medical device user facilities are now subject to mandatoryFDA adverse event reporting requirements for medical devices:. Information concerning FDA'smandatory reporting requirements can be obtained by contacting the Center for Devices andRadiological Health, Office of Surveillance and Biometrics, Division of Surveillance Systems, at301-594-2735. Since the FDA mandatory reporting requirements may not be applicable to allmedical device events, FDA also depends on information voluntarily provided by device usersbecause they are often the first to recognize medical device-related hazards. Any cbncernsthat licensees may have pertaining to the safety or quality problems associated with medicaldevices can be voluntarily reported to the FDA by calling MedWatch at 1-800-FDA-1088.Voluntary reports can be submitted anonymously.This information notice requires no specific action nor written response. If you have anyquestions about the information in this notice, please contact the technical contact listed belowor the appropriate NRC regional office.Donald A. Cool, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand SafeguardsTechnical contact: Robert L. Ayres, NMSS301-415-5746E-mail: rxal@nrc.gov

===Attachments:===
1. List of Recently Issued NMSS Information Notices2. List of Recently Issued NRC Information Notices*Coordinated with FDA** Concurrence by FAX *See previous concurrenceDOCUMENT NAME: H:%TRACI%97-65.INTo receive a copy of this document. Indicate In the box: ACE -Copy without attachment/enclosure ' -Copy with attachment/enclosure 'N-No copyOFFICE lMAB* E IMAB* E AIMB OGC* no legalNAME RAyres CHaney LWCamper JPiccone STrebyDATE 6/30/97 7/1/97 17/1/9/7/997 7129/97I OFFICE TechEdl DD:IMNs I D:lMNS .NAME EKraus FCombs DCoolDATE 6/12/97 6/12/97 6/12197OFFICIAL RECORD COPY IN 97-XXJuly , 1997 Licensees should be aware that medical device user facilities are now subject to mandatory FDAadverse event reporting requirements for medical devices. Information concerning FDA's mandatoryreporting requirements can be obtained by contacting the Center for Devices and RadiologicalHealth, Office of Surveillance and Biometrics, Division of Surveillance Systems, at (301) 594-2735.Since the FDA mandatory reporting requirements may not be applicable to all medical deviceevents, FDA also depends on information voluntarily provided by device users because they areoften the first to recognize medical device-related hazards. Any concerns that licensees may havepertaining to the safety or quality problems associated with medical devices can be voluntarilyreported to the FDA by calling MedWatch at 1-800-FDA-1088. Voluntary reports can be submittedanonymously.This information notice requires no specific action nor written response. If you have any questionsabout the information in this notice, please contact the technical contact listed below or theappropriate NRC regional office.Donald A. Cool, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Robert L. Ayres, NMSS(301) 415-5746E-mail: rxal@nrc.gov

===Attachments:===
1. List of Recently Issued NMSS Information Notices2. List of Recently Issued NRC Information Notices* Coordinated with FDA** Concurrence by FAX *See previous concurrenceOFC IMAB- E IMAB* E WIMA* E IMOB l 0GC- No leall lI I I ~ n m bOUNAME RAyres CHaney LWCamper i neSTrebyDATE 6/30/97 7/1197 1 7/1/97 1 7/29/97.. ...I .OFC I TechEd- I I DdIA I I I DAAAP I I INAME EKraus ___ _ ___DATE 6112/97 7 _1_9_7_ _I_ _ _E.OR.N_ _E.=_ OPFFCILRE O D _OP:_ _N_ _C=COVER E=COVER\ENCLOSURE -N=NO COPY OFFICIAL RECORD COPY:G \IN97XX.RLA IN 97-XXJuly , 1997 Thus, licensees should be aware that medical device user facilities are now subject to mandatoryFDA adverse event reporting requirements for medical devices. Information concerning FDA'smandatory reporting requirements can be obtained by contacting the Center for Devices andRadiological Health, Office of Surveillance and Biometrics, Division of Surveillance Systems, at (301)594-2735. Since the FDA mandatory reporting requirements may not be applicable to all medicaldevice events, FDA also depends on information voluntarily provided by device users because theyare often the first to recognize medical device-related hazards. Any concerns that licensees mayhave pertaining to the safety or quality problems associated with medical devices can be voluntarilyreported to the FDA by calling MedWatch at 1-800-FDA-1088. Voluntary reports can be submittedanonymously.This information notice requires no specific action nor written response. If you have any questionsabout the information in this notice, please contact the technical contact listed below or theappropriate NRC regional office.Donald A. Cool, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Robert L. Ayres, NMSS(301) 415-5746E-mail: rxal@nrc.gov

===Attachments:===
1. List of Recently Issued NMSS Information Notices2. List of Recently Issued NRC Information Notices* Coordinated with FDA** Concurrence by FAX*See previous conurrence510rtk tavOFC lIMAB E IMAcc \ l 13 / 1 IMOB I n she 1NAME l RAyres 0%4 CHaney _____r_l JPiccone _ _ IDATE l 6/30/97 711/97 _ U I7/97 I 71 /97 l 'h F-.......I./OFC I TechEd I IDD/IMNS IDAMNS IINAME j EKraus FCCombs DACoolDATE 6/12/97 71/ 97 7/ /97C-COVER E=COVERXENCLOSUREN=NO COPY OFFICIAL RECORD COPY:G:\IN97XX.RLA IN 97-XXJune, 1997 Licensees should be aware that medical device user facilities are now subject to mandatory FDAadverse eveif reporting requirements for medical devices. Information concerning FDA's mandatoryreporting requtrements can be obtained by contacting the Center for Devices and RadiologicalHealth, Office o}>Surveillance and Biometrics, Division of Surveillance Systems, at (301) 594-2735.Since the FDA mandatory reporting requirements may not be applicable to all medical deviceevents, FDA also d~pends on information voluntarily provided by device users because they areoften the first to reco nize medical device-related hazards. Any concerns that licensees may havepertaining to the safes or quality problems associated with medical devices can be voluntarilyreported to the FDA bypcalling MedWatch at 1-800-FDA-1088. Voluntary reports can be submittedanonymously.This information notice req ires no specific action nor written response. If you have any questionsabout the information in this rotice, please contact the technical contact listed below or theappropriate NRC regional offing\ Donald A. Cool, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Robert L. Ayres, NMSS(301) 415-5746E-mail: rxal@nrc.gov \

===Attachments:===
1. List of Recently Issued NMSS Information Notices\2. List of Recently Issued NRC Information Notices* Coordinated with FDA** Concurrence by FAX A *See previous concurrer~eOC IMAB* I E IMAB* I EE IM lINAME Rayres CHaney LB JPiconeDATE 6/13197 6116197 1 _ _ __7 \ 6/ /97c .1 .1I OFC I TechEd I I DD/IMNS I I D/IMNS I I INAME **EKraus FCCombs DACool \DATE 6/12/97 6/1/97 6/ 197. ...._C=COVER E=COVERIENCLOSUREN=NO COPY OFFICIAL RECORD COPY:GUNISIVIA&KIA 
-S.:'-I.dIN 97-XXJune 1997 Thus, nsees should be aware that medical device user facilities are now subject to mandatoryFDA advse event reporting requirements for medical devices. Information concerning FDA'smandatory porting requirements can be obtained by contacting the Center for Devices andRadiological ealth, Office of Surveillance and Biometrics, Division of Surveillance Systems, at (301)594-2735. Sin the FDA mandatory reporting requirements may not be applicable to all medicaldevice events, A also depends on information voluntarily provided by device users because theyare often the first recognize medical device-related hazards. Any concerns that licensees mayhave pertaining to the safety or quality problems associated with medical devices can be voluntarilyreported to the FDA calling MedWatch at 1-800-FDA-1088. Voluntary reports can be submittedanonymously.This information notice re ires no specific action nor written response. If you have any questionsabout the information in this otice, please contact the technical contact listed below or theappropriate NRC regional offliDonald A. Cool, DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetynd Safeguards

===Technical Contact:===
Robert L. Ayres, NMSS(301) 415-5746E-mail: rxal@nrc.gov

===Attachments:===
1. List of Recently Issued NMSS Information Notices2. List of Recently Issued NRC Information Notices* Coordinated with FDA o qnConcurrence by FAX *See previous concurrenceOFC IMAB*l___ E IMAB I_ _ IMAB I \1410BII_NAME Rayrer__ __ CHaney LWCamper _ __neDATE 6/13/97 6/J?7 61 197 6/____7I ,.IOFCTechEd I IDDAMNS ID/IMNS I.4.V -- -- -- .- _ _ _ _ _ _ _ _ _ _NAME 'EKraus FCCombs DACoolDATE 1 6112197 I6/1/97 1611/97UE~iU~I~ I.2;n AAFU._.7YY In AL;-9.UVtK t_=LUVrtK%=NtLU:iU Kt_NMNU %our IvrrROIAL. KCV_#%JLO %curT7 i -'lIN 97-XXJune .1997 subject to mandatory FDA adverse event reporting requirements for medical devices.Information concerning FDA's mandatory reporting requirements can be obtained bycontacting t Center for Devices and Radiological Health, Office of Surveillanceand Biometric Division of Surveillance Systems, at (301) 594-2735. Since theFDA mandatory porting requirements may not be applicable to all medical deviceevents, FDA als depends on information voluntarily provided by device usersbecause they are ften the first to recognize medical device-related hazards. Anyconcerns that lice sees may have pertaining to the safety or quality problemsassociated with me cal devices can be voluntarily reported to the FDA by callingMedWatch at 1-800-FD -1088. Voluntary reports can be submitted anonymously.This information notic requires no specific action nor written response. If youhave any questions abou the information in this notice, please contact thetechnical contact listed elow or the appropriate NRC regional office.Donald A. Cool. DirectorDivision of Industrial andMedical Nuclear SafetyOffice of Nuclear Material Safetyand Safeguards

===Technical Contact:===
Robert L. Ayres, N S(301) 415-5746E-mail: rxal@nrc.gov

===Attachments:===
1. List of Recently Issued NMSS Informatio Notices2. List of Recently Issued NRC Information tices* Coordinated with FDAConcurrence by FAX0FC.IMAB I f IMAB l I MAB l IMOB I INAME j Rayres A CHaney LWCamper JPicconeDATE 6/J3/976/9797 6/ /97 \ 6/ /97 ____OFCTechEd IDD/IMNS ID/IMNSINAME **EKrause FCCombs DACoolDATE 6/12/97 6/ /97 *6/ /971- .M Ir r -,L AI^ ,.Rr%' .X r A , r-rT, T
* Irt?-Tr, rnv r% tI,=tU~tKtt=UUtK\tNLULU-.UKtN=N0 COPTUrrAA UAL KtLISUKUCUr T :\1: XIN,97XX.RLA}}

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