NOVOSTE/30MM BETA-CATH/SYSTEM
Received Dec 13, 2001 · Event occurred Nov 30, 2001
Report 1062385-2001-00026 · MDR key 366521
Device
Generic name
Transfer Device/catheter
Manufacturer
Novoste Corp.Model number
A1732/510609-030Catalog number
WLC-0001-032/BCK-0130
Lot number
NA/473553
Product problems
- Fluid/Blood Leak
- Replace
Patient
51 YR
- Chemical Exposure
Narrative
Description of Event or Problem
IN PREPARATION FOR A VASCULAR BRACHYTHERAPY PROCEDURE, THE 30MM TRANSFER DEVICE AND CATHETER WERE TESTED AND WATER LEAKAGE INTO THE STERILE BAG WAS EXPERIENCED. DURING TROUBLESHOOTING 5 SOURCES WERE OBSERVED ON THE FLOOR. II SOURCES WERE EVENTUALLY LOCATED, WITH THE 12TH SOURCE SUSPECTED TO BE INSIDE THE TRANSFER DEVICE (TD IS STILL HOT). NO MISADMINISTRATION OCCURRED, AS THE DEVICE WAS NOT USED TO TREAT A PATIENT. TLD AND FILM BADGES OF THE PERSONNEL INVOLVED WERE PROCESSED, AND THE DOSE WAS FOUND TO BE NEGLIGIBLE. A 40MM TRANSFER DEVICE AND CATHETER WERE USED TO TREAT THE PATIENT. SITE REPORTED THAT NO SEEDS WERE LOST, PRODUCTS WILL BE RETURNED TO NOVOSTE FOR EVALUATION.