MalfunctionMOU

3.5F BETA-RAIL TM DELIVERY CATHETER

Received Aug 9, 2002 · Event occurred Aug 8, 2002

Report 1062385-2002-00034 · MDR key 411833

Device

Generic name

Catheter

Manufacturer

Novoste Corp.

Model number

P00563

Catalog number

ABR-0340

Lot number

UNK

Product problems

Detachment Of Device Component
Device, or device fragments remain in patient

Patient

Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

COMPLAINANT REPORTED THAT WHILE WITHDRAWING THE 3.5F BETA-RAIL CATHETER, THE TIP OF THE CATHETER DETACHED AND WAS LEFT IN THE PT. THE PT'S CONDITION IS CURRENTLY STABLE.