BETH CATH ACTIVE TRANSFER DEVICE
Received Sep 27, 2019 · Event occurred Jun 14, 2019
Report 9128812 · MDR key 9128812
Device
Product problems
- Positioning Failure
- Failure to Advance
- Physical Resistance/Sticking
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE EVENT HAPPENED IN THE INTRAVASCULAR BRACHYTHERAPY (IVBT) PROCEDURE. THE PROCEDURE IS TO DELIVER RADIATION TO ATHEROSCLEROTIC CARDIAC VESSEL. A TRANSFER DEVICE IS USED TO DELIVER THE SR-90 RADIATION SOURCE, WHICH IS INSIDE THE CATHETER, TO THE DISEASED CARDIAC ARTERY. THE PATIENT WAS TREATED PROPERLY. AT THE END OF THE PROCEDURE, WHEN BEING RE-TRACKED BACK TO THE DEVICE, THE RADIATION SOURCE STUCK INSIDE THE CATHETER. RADIATION ONCOLOGIST AND CARDIOLOGIST IMMEDIATELY REMOVED THE CATHETER (WITH RADIATION SOURCE INSIDE) FROM THE PATIENT. THE RADIATION ONCOLOGIST AND PHYSICIST IMMEDIATELY PUT THE MALFUNCTIONED DEVICE AND CATHETER (WITH SOURCE INSIDE) INTO EMERGENCY RADIATION SHIELDING BOX. THE PHYSICIST SURVEY THE PATIENT AND ROOM TO MAKE SURE NO SOURCE LEFT BEHIND. THERE WAS NO RADIATION EXPOSURE TO PATIENT OR THE STAFF. THE RADIATION OFFICE WAS NOTIFIED. THE MALFUNCTIONED DEVICE AND STUCK SOURCE ARE CURRENTLY STORED PROPERLY.