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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 56867 | 20 November 2023 06:00:00 | Agreement State | Equipment Failure | The following information was provided by the Texas Department of State Health Services (the Department) via email: On November 21, 2023, the licensee's radiation safety officer notified the Department that on November 20, 2023, during an intravascular brachytherapy (IVB) procedure, the strontium-90 source train did not reach the dwell position within 15 seconds. When they attempted to retract the source, it would not retract into the fully shielded position in the device, but it was outside the patient. Following established procedures, the delivery system (catheter, source train, etc.) was removed from the patient and placed in the device's emergency box. There were no overexposures to the patient or staff. The licensee used a second device and completed the IVB procedure on the patient. After a short time, the licensee was able to return the source train to the fully shielded position in the device. The manufacturer's representative will be coming onsite to perform an evaluation. The licensee did observe what appeared to be a possible kink in the catheter. More information will be provided as it is obtained in accordance with SA-300. Device Information: Best Vascular Novoste IVB model A1000 Source Information: Source train of 16 strontium-90 sources, current total activity 35.9 millicuries. Texas Incident Number: 10067 Texas NMED Number: TX230053 | ||
| ENS 55222 | 28 April 2021 06:00:00 | Agreement State | Medical Event | The following was received via e-mail from the Texas Department of State Health Services: The licensee reported that on April 28, 2021, a medical event involving a High Dose Rate (HDR) afterloader gynocological treatment, using a Varian VariSource iX device, with an iridium-192 sealed source of 6.93 curies, at the time of treatment, had occurred at is facility. The wrong length transfer tube was used which resulted in a dose of 600 centigray, the intended dose fraction, to an area, mostly skin, approximately 12 centimeters from the intended treatment site. The authorized user does not expect any harm to the patient. The patient has been informed. More information will be provided as it is obtained in accordance with SA-300. Texas Incident Number: 9843 A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 55033 | 11 December 2020 06:00:00 | Agreement State | Unretractable Source | The following report was received from the Texas Department of State Health Services (the Agency) via email: On December 12, 2020, the Agency was notified by the licensee's radiation safety officer (RSO) that on December 11, 2020, they were unable to retract a source string composed of 16 strontium - 90 sources with a total activity of 36 milliCuries to the fully shielded position. The RSO stated they had completed the treatment of a patient using a Best Vascular model A1000 brachytherapy device and Novoste Beta-Cath Delivery System and when they attempted to retract the source to the shielded position, the source stuck just outside the device. The source did retract outside the patient. The source and associated equipment were placed in a shield box and have been placed in storage. The RSO stated neither the patient or individuals operating the device received any additional exposure from the event. The RSO stated the patient received the prescribed dose from the treatment. Additional information will be provided as it is received in accordance with SA-300. Texas Incident Number: 9816 | ||
| ENS 49089 | 3 June 2013 05:00:00 | Agreement State | Agreement State Report - Source Retraction Failure | The following was received from the State of Texas via email: On June 3, 2013, the Agency (State of Texas) was notified by the licensee that on June 3, 2013, a medical event had occurred. The licensee reported a source retraction failure with a Novoste Beta-Cath intravascular brachytherapy system containing a 45.1 mCi strontium - 90 source. When the treatment was completed, upon source retraction, the source got stuck in another area of the blood vessel roughly 5 cm away from the treatment site for 1 minute. The unintended absorbed dose to that area of the vessel is in the range of 5-6 Gy. The source open in air time was roughly 3 seconds from being retracted from the patient before being secured in a bail out box. Personnel exposure issues or concerns are not expected, however, dosimeters will be assessed. A technical representative was notified and during the next several days will inspect the system and assist in packaging the system for return shipment back to the manufacturer. Additional information will be provided as it is received in accordance with SA-300. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. * * * UPDATE FROM CHRIS MOORE TO PETE SNYDER AT 1118 EDT ON 6/14/13 * * * The following updated information was provided from the State of Texas via email: The Methodist Hospital reported an equipment failure that involved a source retraction during an intravascular brachytherapy treatment performed on 6/3/2013. The intravascular brachytherapy system (Best Vascular Beta-Cath A1000 series) contained a 1.67 GBq (45.1 mCi) Sr-90 source. When the treatment was completed and upon source retraction, the source became stuck in another area of the blood vessel approximately 5 cm from the treatment site for one minute. The unintended absorbed dose to the area of the aortic arch was approximately 40 cGy at 10 mm on the wall of the arch. A technical representative was notified and will inspect the system within the next several days and assist in packaging the system for return to the manufacturer. The State of Texas determined that this event is no longer classified a medical event and has been updated to equipment failure. Notified R4DO (Gepford) and FSME Events Resource email. Texas Incident #: I-9088 | ||
| ENS 48640 | 4 December 2012 06:00:00 | Agreement State | Therapy Source Jammed at the Device Entry Port | On January 2, 2013, the Agency (Texas Department of State Health Services) was notified by the licensee that on December 4, 2012, a medical event had occurred. The licensee reported that while performing a therapy procedure using a Novoste Beta-Cath IVB device the last strontium-90 source in the ribbon of sources could not be retracted into the device. The source was jammed at the device entry port. All of the sources had been removed from the patient, therefore the patient did not receive any additional exposure. The device was placed into an emergency safety box designed for such events and the box was then covered with a lead apron. No one in the treatment room received any additional exposure form the event. The licensee will return the device to their supplier. Additional information will be provided as it is received in accordance with SA-300. Texas State Report # I-9029
The following information was received by facsimile: The Best Vascular Technical Team based in Norcross, Georgia evaluated the returned system that was involved in the subject complaint. The team confirmed the complaint based on the evidence of discoloration to the proprietary connector and acrylic body of the main chamber distal to the pin gate, indicating prolonged exposure to radiation; however upon arrival the Jacketed Radiation Source Train (JRST) was no longer stuck at the pin gate or proprietary connector of the delivery catheter. During testing, interlocks performed as expected to provide safety in the case of a manual removal. The team was unable to duplicate the complaint after exhaustive cycle testing. Visual examination identified a kink in the tubing leading to the fluid collection bag. A fluid sample that had been run through the transfer device and over the jacketed radioactive source train was analyzed for unsealed radiation; no radiation leakage was detected. Due to the size of the 3.5F delivery catheter, Best Vascular utilizes tubing materials that exhibit high column strength to ensure adequate trackability of the catheter during placement. The smaller size of the catheter is a desired feature that minimizes ischemia caused by cessation of blood flow during treatment. Unimpeded hydraulic flow is essential to performance of the system and as such, it is necessary to avoid the compression that may occur to the delivery catheter due to the configuration of the system in conjunction with other interfaces (e.g., interventional tools, patient, etc.). It is also essential that the path to the fluid collection bag be maintained in an unobstructed manner in order to provide the hydraulic pressure necessary for smooth movement of the JRST through the entire system. Additional information on this event has been provided in the Nuclear Materials Event Database in accordance with SA-300. Notified R4DO(Miller) and FSME via email. A Medical Event may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient. | ||
| ENS 47952 | 10 April 2012 05:00:00 | Agreement State | Agreement State Report - Stuck Source in Catheter | The following the received via e-mail: On May 23, 2012, the Agency (State of Texas) was notified by the licensee that on April 10, 2012, while the licensee was performing a routine quality assurance test using a beta catheter system device, the 50.2 milliCurie Strontium-90 source train jammed as it began to move from the transfer device to the test catheter. The source train was lodged near the transfer device exit port and could not be returned to the home position. After a few failed attempts to retract the source train, the applicator and phantom were covered with a lead apron, and the manufacturer's Radiation Safety Officer was notified. A manufacturer's technician arrived at the licensee's Hot Lab the morning of April 11, 2012. The technician was not able to return the source to the shielded position. The device was returned to the manufacturer's facility for analysis. Since this fault occurred during routine quality assurance testing, no patient was involved in the procedure. The manufacturer inspected the catheter and found a deformation in the catheter that would have interfered with the source movement. The source was leak tested, and the results indicated that the source was not leaking. The source train has been removed from service. Additional information will be provided as it is received in accordance with SA - 300. TX Incident # I-8956 | ||
| ENS 45708 | 10 December 2008 06:00:00 | Agreement State | Agreement State Report - Source Stuck in Catheter Tube | The following information was obtained from NMED: The Methodist Hospital reported that a 1.91 GBq (51.57 mCi) Sr-90 source (BEBIG model Sr0.S03, serial #ZB523) became stuck in a catheter during a patient's treatment on 12/10/2008, using a Novoste Beta-Cath system (model A1732, serial 91277). The catheter was removed from the patient and placed into a bailout box. The bailout box was returned to storage and additional shielding was used to ensure dose rates in the area were ALARA. There was no additional exposure to any individual involved. A preliminary visual inspection of the device indicated that there may be a small kink in the capillary tube, which prevented the source from returning to its secured location. The source was returned to the manufacturer for further investigation. The manufacturer determined that the source became stuck due to kinks in the delivery catheter. They provided additional guidance to the hospital in the use of the system to help minimize recurrence. The State of Texas discovered that the event was reported to NMED but not to the NRC Headquarters Operations Center as required therefore they are making a late report. Texas Report Number: I-8590 | ||
| ENS 40967 | 28 July 2004 05:00:00 | Agreement State | Source Train Did Not Retract | After IVB therapy the source train did not retract due to a kink in the IVB catheter, did not retract to the remote Beta-Cath device. The IVB catheter was immediately withdrawn and placed in the Novoste emergency plexiglass storage safe and then in the IVB storage room. No overexposure was received by the patient or attending staff. Novoste has been notified of the malfunction. The Novoste Beta Cath was returned to the manufacture on August 2, 2004. The IVB manufacturer is Novoste Beth Cath, source Sr-90, 1.71 GBq (46 millicuries). Transfer device Serial No. 92917, and Source train Serial No. ZA543. The device was packaged and returned to the manufacturer on August 2, 2004. This agency did not receive notice of the event within 24-hours Texas Incident No.: I-8155 | ||
| ENS 40430 | 5 January 2004 14:16:00 | Agreement State | Agreement State Report: Novoste Strontium-90 Intravasular Brachytherapy (Ivb) Source Discovered Missing. | Novoste Strontium-90 Intravascular brachytherapy (IVB) source (remote afterloader) was discovered missing on January 5, 2004. Source was last seen but not used on December 17, 2003. Reported by phone by RSO. Source is a small handlheld device - Manufacturer: Novoste, Model: BethCath, Serial No. 92607; Source train Serial No. ZB-520; Original Activity 55.62 millicuries; current activity (date of discovery) 54.64 millicuries; Calibration date: 04/11/2003; Last leak test 10/29/2003. Received at the hospital on November 4, 2003. Last used in a patient on December 5, 2003 (first and last use). Last seen on during a functional test on December 17, 2003 in the Fondren Building, Room F1099 (near cath lab) at the Licensee's main site 6565 Fannin Street, Houston, Texas. The source was not used that day. Two other sources of different activity and length remain in storage. The room and cath lab have been search 4 times by the Licensee's staff. Trash has been surveyed. Hospital staff has been notified of the missing equipment.. Texas Incident No.: I-8089. |