Information Notice 1998-10, Probable Misadministrations Occurring During Intravascular Brachytherapy with Novoste Beta-cath System

Probable Misadministrations Occurring During Intravascular Brachytherapy with Novoste Beta-cath System

ML031050256
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	03/09/1998
From:	Cool D Office of Nuclear Material Safety and Safeguards
To:
References
IN-98-010, NUDOCS 9803030106
Download: ML031050256 (9)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 March 9, 1998 NRC INFORMATION NOTICE 98-10: PROBABLE MISADMINISTRATIONS OCCURRING

DURING INTRAVASCULAR BRACHYTHERAPY WITH

THE NOVOSTE BETA-CATH SYSTEM

Purpose

The U.S. Nuclear Regulatory Commission is issuing this information notice to alert addressees

to two reported incidents that have occurred during the conduct of intravascular brachytherapy

procedures using the Novoste Beta-Cath system. This system uses Strontium-90 high-dose- rate (HDR) source trains that can range between approximately 1 to 10 Gy/min beta dose

output at the surface of the seeds. Licensees should be aware of the potential for similar

failures during the course of patient treatments and the possible risk(s) for misadministrations

and potential patient harm resulting from the inability to retract these HDR sources at the

conclusion of the planned treatment. It is expected that recipients will review the information for

applicability to their facilities and consider actions, as appropriate, to avoid similar problems.

However, suggestions contained in this information notice are not new NRC requirements;

therefore, no specific action nor written response is required.

Description of Circumstances

NRC has become aware of two reported failures, while using the Novoste Beta-Cath system for

intravascular brachytherapy in multi-center clinical trials. Both of these events are being

investigated as probable misadministrations (wrong treatment sites) as the sources failed to

return to the device storage safe at the conclusion of the treatments. The Sr-90 source train

was observed leaving the treatment site but did not return to the device; in fact, the precise

locations of the sources were unknown for some period of time. A brief summary of the two

reported failures follows:

1. On January 16, 1998, an NRC licensee reported that on January 15, 1998, a

patient receiving treatment with the experimental Novoste Beta-Cath device

received a larger than expected dose to unwanted body areas because of

difficulty in removing the inserted sources. Twelve Sr-90 sources (total activity of

1.3 x 109 Bq (35 mCi)) were inserted in the treatment location via a long catheter.

At the conclusion of the treatment the pellets became stuck in the catheter,

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IN 98-10

March 9, 1998 requiring the immediate removal of the catheter containing the sources from the

patient. Because of the time needed to remove the catheter (estimated to be 65 seconds) the patient received a larger transit dose than expected, as the normal

source transit time is on the order of 3 to 5 seconds; and,

2. On February 9, 1998, the State of Washington notified NRC of a somewhat

similar incident reported by one of its licensees as occurring on December 15,

1997. In this misadministration report the licensee reported that at the

conclusion of a 3-minute and 32-second treatment (18 Gy dose at 2mm) to the

left coronary artery the hydraulic source transport system (syringe) ran out of

saline, stalling the source train in transit. It reported that the source train was

stalled at an unknown location for 1 minute and 32 seconds delivering an

additional unintended 7.8 Gy (maximum) dose to the vessel wall(s).

Although investigation of both of the reported events is ongoing, presently available information

attributes the failure of the source transport system in the first event to crimping of the Novoste

system catheter by over-tightening of the Touhy-Bourst valve used to tighten around the

catheter and prevent the flow of blood out of the insertion point in the patient's femoral artery.

This crimp did not completely close the source lumen in the Novoste catheter, allowing the

saline flow to continue, but it was sufficient to block the sources from returning to the device.

When the saline supply in the delivery syringe was exhausted, an emergency removal of the

Beta-Cath treatment catheter from the patient was performed.

In the second reported incident, the syringe saline supply was also exhausted before the

sources were returned to the device source storage location. In this event, the syringe was

replaced with a fresh supply of saline and the sources were then successfully returned to their

storage location using the device's hydraulic source transport system. It is possible that the

second reported event may have the same root cause as the first, but this has not yet been

determined.

In both events, the respective authorized users report that they do not expect any adverse

health consequences for the patients involved.

Discussion:

Numerous clinical trials are underway to evaluate the feasibility of using intravascular

brachytherapy to prevent restenosis after angioplasty in coronary and peripheral arteries.

These trials involve numerous new and innovative sources of byproduct materials and delivery

systems that, in most cases, have not undergone formal sealed source and device'reviews and

listing in NRC's Registry of Sealed Sources and Devices as approved source(s) and device(s)

for this intended use.

In the first cited event report from our NRC licensee, the immediate cause of the incident

appears to be transient damage to the Beta-Cath system source lumen (catheter), because of

over-tightening of the Touhy-Bourst valve (this is a valve-like device located at the proximal end

of the guide catheter, 15 to 20 cm beyond the external skin surface, and contains an iris-like

IN 98-10

March 9, 1998 shutter designed to tightly grip the Beta-Cath catheter to prevent leaking of blood around the

catheter). It is necessary to loosen this valve each time the Beta-Cath source train is moved to

or from the transfer device to the treatment site at the distal end of the catheter. Subsequent

simulation of the misadministration incident by the licensee showed that tightening the Touhy- Bourst valve one-half turn beyond ufinger-tight" created a condition where the sources could not

be retracted back into the device. On visual examination, a small depression was clearly

evident on the catheter at the location of the Touhy-Bourst valve. Loosening, or even removing

the valve did not allow retraction of the source train. After about 20 minutes, it was possible to

retract the sources normally with the device's hydraulic transport system. It is believed that, over this 20-minute period, elastic restoring forces reduced the indentation in the catheter to the

point where the sources could be retracted normally.

At this time, less information is available concerning the second event reported by the

Washington State licensee. However, discussions with Novoste revealed that a second source

transfer failure mechanism exists with this device design.

Specifically, if too much pressure is applied to the saline supply syringe during source transport, the supply of saline can be prematurely exhausted before completing the intended source

transport procedure. Thus, it appears that at least two source transport failure modes exist that

can be induced by the improper application of force in the operation of the device by the user.

In the extensive investigation of its event, our licensee identified a number of factors that it

believes contributed to the reported misadministration. These were: (1) The device design

allows for over-tightening of the Touhy-Bourst valve, which can block the source train transport

pathway; (2) excessive intervals of time between training and start of clinical procedures and

successive clinical procedures; (3) less than optimal didactic and practical training; (4) between

extremely limited opportunities for self-practice and rehearsal because of restrictions imposed

by Novoste; and, (5) lack of a detailed checklist, describing all precautionary checks and

warnings, including manipulation of the Touhy-Bourst valve.

During the course of the NRC investigation of these events, an additional possible design

related source transport system failure mode was discovered that should be added to the above

listing. Specifically, when attaching the syringe to the transfer device, over-tightening of the

syringe Luer to the extension connector may cause the sterile sleeve to be pinched, which, could result in the inability to produce sufficient hydraulic pressure. Inclusion of related

operational procedures and warnings, addressing all these failure modes should be included in

the check-list cited in the preceding paragraph.

The following corrective actions, proposed by our licensee's medical physicist, may be

beneficial in addressing radiation safety concerns related to the use of this device in ongoing

clinic trials:

1. Improve radiation oncology training quality, including didactic review of relevant

interventional cardiology procedures and technical details, as well as more

realistic training exercises in a catheterization lab environment;

IN 98-10

March 9, 1998 2. Develop an appropriately modified version of American Association of Physicists

in Medicine's HDR device quality assurance protocol that gives confidence that

all Novoste treatment equipment is functioning properly. At a minimum, this

should include: (a) daily testing of all treatment units before treating patients; (b)

testing of treatment catheter with the randomly selected radiation afterloading

device (RAL) before positioning the catheter in the patient; (c) where ischemia is

not a problem, test the inserted catheter with the dummy source RAL for

unobstructed passage of the sources before attaching the randomly selected

device to the catheter and administering therapy; and, (d) verification of source

strength and/or prescription dose rate;

3. Be conscious of the possibilities for damaging the treatment catheter before and

during the radioactive source treatment and develop a list of precautions to be

made known to all participants;

4. Develop a check list of essential steps, checks, and precautions to be followed in

executing these treatments and verbally review this list step by step until

procedure frequency and competence are built up;

5. Develop a mechanism for facilitating self-initiated practice and procedure review.

This requires vendor cooperation;

6. Redesign the treatment-to-guide catheter Interface to eliminate the possibility of

catheter damage.

The post-incident investigation and resultant proposed corrective actions appear to be

appropriate. Certain of these actions, specifically numbers 1, 3, and 4, can be unilaterally

implemented by the licensee. However, the remaining three actions require the approval and

support of Novoste Corporation.

All licensees contemplating use of the Novoste Beta-Cath system or any of the other emerging

intravascular brachytherapy procedures should ensure that either: (1) the device(s) and/or

source(s) have undergone a thorough radiation safety review and approval by the NRC or

Agreement State, as required by 10 CFR 35.49(a); or, (2) for broad scope licensees, who are

exempted from the requirements of 10 CFR 35.49(a) through a standard license condition, an

equivalent radiation safety evaluation by a broad scope licensee's radiation safety committee

should be performed in order to fully satisfy the requirements of 10 CFR 33.13(c)(3)(ii). In

addition, licensees should ensure that affected personnel understand all operating parameters

necessary for the safe operation of the system. If significant unaddressed safety concerns

remain, then it would be expected that the licensee would decline to participate in that particular

clinical trial.

IN 98-10

March 9,1998 This information notice requires no specific action nor written response. If you have any

questions about the information in this notice, pi se t T4he technical contact listed below

or the appropriate NRC regional office. t

AD aid ool, Director

sion of Industrial and

Mdical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Robert L. Ayres, NMSS

(301) 415-5746 E-mail: rxal@nrc.gov

Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

Lo Le LA &W

K i

Xffachment 1 IN 98-10

March 9,1998 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

98-09 Collapse of an Isocam II, Dual- 3/5/98 All medical licensees

Headed Nuclear Medicine Gamma

Camera

98-08 Information Likely to be Requested 3/3/98 All parts 30, 40, 70, 72 and 76 if an Emergency is Declared licensees and certificate holders

required to have a Nuclear

Regulatory Commission approved

Emergency plan.

98-06 Unauthorized use of License 2/19/98 All NRC Licensees authorized

to Obtain Radioactive Materials, to Possess Licensed Materials

and its Implications Under The

Expanded Title 18 of the U.S. Code

98-04 1997 Enforcement Sanctions for 2/9/98 All U.S. Nuclear Regulatory

Deliberate Violations of NRC Commission licensees.

Employee Protection

Requirements

98-01 Thefts of Portable Gauges 1/15/98 All portable gauge licensees

97-91 Recent Failures of Control 12/31/97 All industrial radiography

Cables Used on Amersham licensees

Model 660 Posilock Radiography

Systems

97-89 Distribution of Sources and 12/29/97 All sealed source and device

Devices Without Authorization manufacturers and distributors

97487 Second Retrofit to Industrial 12/12/97 All industrial radiography

Nuclear Company IR100 licensees

Radiography Camera, to

Correct Inconsistency in

10 CFR Part 34 Compatibility

97-86 Additional Controls for Transport 12/12/97 Registered users of the Model

of the Amersham Model No. 660 No. 660 series packages, and

Series Radiographic Exposure Nuclear Regulatory Commission

Devices industrial radiography licensees

'-

'--ttachment

IN 98-10

March 9, 1998 Page 1 of I

LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

98-07 Offsite Power Reliability 2/27/98 All holders of operating licensees

Challenges from Industry for nuclear power reactors

Deregulation

98-06 Unauthorized Use of License to 2/19/98 All NRC licensees authorized to

Obtain Radioactive Materials, possess licensed material

And Its Implications Under The

Expanded Title 18 of the

U.S. Code

97-45, Supp. 1 Environmental Qualification 2/17/98 All holders of operating

Deficiency for Cables and licenses for nuclear power

Containment Penetration reactors except those licensees

Pigtails who have permanently ceased

operations and have certified that

the fuel has been permanently

removed from the reactor vessel

98-05 Criminal History Record 2/11/98 All holders of operating

Information licenses for power reactors

98-04 1997 Enforcement Sanctions for 2/9/98 All U.S. Nuclear Regulatory

deliberate Violations of NRC Commission licensees

Employee Protection requirements

98-03 Inadequate Verification of 1/21/98 All holders of operating licenses

Overcurrent Trip Setpoints in for nuclear power reactors

Metal-Clad, Low-Voltage

Circuit Breakers

98-02 Nuclear Power Plant Cold. 1/21/98 All holders of operating licenses

Weather Problems and for nuclear power reactors

Protective Measures

98-01 Thefts of Portable Gauges 1/15/98 All portable gauge licensees

OL = Operating License

CP = Construction Permit

IN 98-10

March 9, 1998 This information notice requires no specific action nor written response. If you have any

questions about the information in this notice, please contact the technical contact listed below

or the appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Robert L Ayres, NMSS

(301) 415-5746 E-mail: rxal@nrc.gov

Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

• Coordinated with FDA, RIII, State of Washington, and manufacturer

• • See Previous Concurrence

OFC IMAB* TK I E DMlI

NAME RAyres 6HM LWCamper JPiewmn

DATE 2/25198 2//98 2/26198 _ I__ _

• ~~

.

OFC **TechEd I DD/IMNS* I D/IMNS* I I

NAME EKraus FCCombs DACool _

DATE 2118/98 2/27/98 2/26/98 __________

C=COVER E=COVERIENCLOSURE N=NO COPY OFFICIAL RECORD COPY: G:UN98XX.RLA

IN 98-XX

February , 1998 If significant unaddressed safety concerns remain, then it would be expected that

the licensee would decline to participate in that particular clinical trial.

This information notice requires no specific action nor written response. If you

have any questions about the information in this notice, please contact the

technical contact listed below or the appropriate NRC regional office.

Donald A. Cool, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Robert L. Ayres, NMSS

(301) 415-5746 E-mail: rxal@nrc.gov

Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

• Coordinated with FDA, RIII, State of Washington, and ma facturer

• • See Previous Concurrence M gi g

OFC l IMAB I ICl IAB / l IMAB l l IM-QB 12 NAME RAyres 4 Cvy LWCam__r JPi__e1 DATE 2/2S/98/ _/98 _ _ _

_2/1//98_ 2/ - /98 OFC **TechEd I D/IMNg-: I

NAME EKrause l a l l iif._}_ _

DATE 2/18/98 1 2/M1198 j 2A/('/98 l

C-COVER E=COVER\ENCLOSURE N=-NO COPY OFFICIAL RECORD COPY: G:\IN98XX.RLA