BIOGRAFT TUNNELER
Received Dec 2, 2003 · Event occurred Jul 30, 2003
Report 6000072-2003-00056 · MDR key 499308
Device
Generic name
Plastic Tunneler
Manufacturer
Boston Scientific WayneModel number
323456Catalog number
323456
Lot number
UNK
Product problems
- Device Slipped
Patient
NO INFO
- Dural Tear
- Bleeding
- Death
- Renal Failure
- Blood pressure, low
- Surgical procedure, additional
- Blood Loss
Narrative
Description of Event or Problem
THE HOSPITAL CLAIMS THAT AN AORTO-BIFEMORAL BYPASS PROCEDURE ENDED UP WITH AN AXILLO-FEMORAL BYPASS. DURING THE PROCEDURE, THE TUNNELER SLIPPED, BUT THERE DID NOT APPEAR TO BE ANY "DAMAGE" TO THE PT. HOWEVER, AFTER CLOSING, THE PT'S BLOOD PRESSURE DROPPED REMARKABLY. THE PT WAS THEN OPENED UP AGAIN. IT WAS OBSERVED THAT THERE HAD BEEN BLEEDING THAT HAD STOPPED. THE PLASTIC TUNNELER WAS FOUND TO HAVE SLICED THROUGH THE LIVER AND STOMACH WALL. THE PT DIED LATER FROM MASSIVE BLEEDING AND KIDNEY FAILURE. PLASTIC BIOGRAFT TUNNELING DEVICES HAVE NOT BEEN SOLD BY BOSTON SCIENTIFIC/MEADOX SINCE 1990. THAT PART OF THE BUSINESS WAS SOLD TO BIOVASCULAR. BOSTON SCIENTIFIC HAS BEEN ATTEMPTING TO LOCATE BIOVASCULAR TO INFORM THEM OF THIS INCIDENT AND PT DEATH.