NOVOSTE BETACATH SYSTEM
Received May 5, 2009 · Event occurred Apr 28, 2009
Report 1381021 · MDR key 1381021
Device
Generic name
Catheter, Brachytherapy, Intracavity, Icrt
Manufacturer
Best Vascular, Inc.Model number
*Catalog number
*
Lot number
BETA-CATH 3.5R SYSTEM
Product problems
- Kinked
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
NOVOSTE BETACATH SYSTEM: THE ICRT CATHETER WAS KINKED SO THE SR-90 RADIOACTIVE TRAIN COULD NOT BE SENT BACK TO THE DEVICE. AFTER THE TREATMENT WAS FINISHED, MD TIED TO PUSH THE SR-90 RADIOACTIVE SOURCE BACK TO THE DEVICE, THE SOURCELEFT THE TREATMENT AREA AND WAS STUCK IN THE CATHETER JUNCTION OUTSIDE OF THE PATIENT'S BODY. MD SAID THE CATHETER HAD A KINK AT THE JUNCTION. THE CATHETER WAS PULLED OUT FROM THE PATIENT'S BODY AND DUMPED IN A SHIELDED TRANSPORTATION BOX WITH WHOLE DEVICE. THE PATIENT AND ROOM WAS SURVEYED USING RADIATION SURVEY METER. NO RADIATION WAS FOUND INSIDE THE PATIENT BODY AND IN THE TREATMENT ROOM OF THE CARDIAC CATH LAB.