ENS 53531
ENS Event | |
|---|---|
05:00 May 14, 2015 | |
| Title | Agreement State Report - Brachytherapy Source Did Not Fully Retract |
| Event Description | The following report was received by e-mail from the state of Illinois:
During a routine inspection [Illinois Emergency Management] Agency inspectors discovered an unreported event that occurred on May 14, 2015. On that date an intravascular brachytherapy procedure was attempted using two BRX-0346 extra-long delivery catheters with a Novoste transfer device and a 40mm Best Vascular, Inc. Sr-90 source train. On the initial treatment attempt, the source would not extend to the treatment location and was promptly returned to the transfer device. A kinked catheter was suspected and a second BRX-0346 XL catheter was put in place. The same train was sent into the second catheter and the same inability to reach the treatment location encountered. At this point, the hydraulic return mechanism failed to return the source train to the transfer device. The licensee's emergency procedure was employed and the entire system was manually removed from the patient. The transfer device, delivery catheter and source train were placed in a temporary storage container and locked in the hot lab. The patient was surveyed and no radioactivity was found to be above background. The treatment was aborted. The licensee was able to determine that a deformation in the delivery catheter impeded movement of the source train to the treatment location. The source was found to be lodged in the catheter, approximately 11.3 cm from the attachment point to the transfer device. As a result, exposure occurred in the aortic root. Estimates on the exposure to the surrounding tissue is pending from the licensee. Best Vascular representatives were reportedly notified and arrived at the licensee's site the following day for evaluation and return shipping to the manufacturer. A deformation in the catheter was confirmed as the root cause. The event was not reported to the State. Supporting documentation was reviewed on 7/30/18 and determined to be, at a minimum an equipment-related event. Pending exposure estimates, this is also being entered as a possible medical event and will remain open while the investigation continues. Radionuclide: Sr-90 Activity: 58.65 mCi (2.17005 GBq) Dose: 18.4 rad (184 mGy) Illinois Item Number: IL180031 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. |
| Where | |
|---|---|
| Alexian Brothers Medical Center Elk Grove Village, Illinois (NRC Region 3) | |
| License number: | IL-01418-01 |
| Organization: | Illinois Emergency Mgmt. Agency |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+28164.17 h1,173.507 days <br />167.644 weeks <br />38.579 months <br />) | |
| Opened: | Gary Forsee 17:10 Jul 30, 2018 |
| NRC Officer: | Bethany Cecere |
| Last Updated: | Jul 30, 2018 |
| 53531 - NRC Website | |
Alexian Brothers Medical Center with Agreement State | |
WEEKMONTHYEARENS 562722022-12-14T06:00:00014 December 2022 06:00:00
[Table view]Agreement State Patient Underdose ENS 541402019-07-01T05:00:0001 July 2019 05:00:00 Agreement State Agreement State Report - Medical Event ENS 538592019-02-04T06:00:0004 February 2019 06:00:00 Agreement State Agreement State Report - Underdose Exceeding 20 Percent of the Prescribed Dose ENS 535312015-05-14T05:00:00014 May 2015 05:00:00 Agreement State Agreement State Report - Brachytherapy Source Did Not Fully Retract 2022-12-14T06:00:00 | |