ENS Event | |
|---|---|
19:30 Apr 17, 2005 | |
| Title | Part 21 Report - Malfunction Of Novoste Intravascular Brachytherapy Beta-Cath System Transfer Device |
| Event Description | During a medical procedure on a patient, two individual coronary artery locations were being irradiated with Sr-90 (2.05 GBq, serial # ZA-494. The device being used, Novoste Intravascular Brachytherapy Beta-Cath System Transfer (S/N# 90556], hereinafter called "Device", failed to work properly.
The licensee noticed the source did not retract into the Device. At this point the licensee pulled the entire catheter out of the patient, and within one minute was able to return the sources safely into the Device. It was assumed the problem was with the catheter and it's connection to the Device. The licensee continued to the next location on the patient. Upon attempting to return the source, the licensee noticed the sources were not moving from the patient. Within 5-10 seconds, the licensee pulled the entire catheter from the patient, and then placed the entire system into the "bailout" box for proper shielding from beta radiation. The next day the licensee called Novoste and explained the events. Novoste determined it was a faulty Device and sent the licensee a replacement. On May 19, 2005 the replacement arrived and the faulty device was sent back to the company. |
| Where | |
|---|---|
| Bryn Mawr Hospital Bryn Mawr, Pennsylvania (NRC Region 1) | |
| License number: | 37-07722-04 |
| Organization: | Bryn Mawr Hospital |
| Reporting | |
| 10 CFR 21.21 | |
| Time - Person (Reporting Time:+764.45 h31.852 days <br />4.55 weeks <br />1.047 months <br />) | |
| Opened: | Michael Bieda 15:57 May 19, 2005 |
| NRC Officer: | John Knoke |
| Last Updated: | May 19, 2005 |
| 41720 - NRC Website | |
Bryn Mawr Hospital with 10 CFR 21.21, Notification of failure to comply or existence of a defect and its evaluation | |
WEEKMONTHYEARENS 417202005-04-17T19:30:00017 April 2005 19:30:00
[Table view]10 CFR 21.21, Notification of failure to comply or existence of a defect and its evaluation Part 21 Report - Malfunction of Novoste Intravascular Brachytherapy Beta-Cath System Transfer Device 2005-04-17T19:30:00 | |