MalfunctionMOU
BETA-RAIL 3.5F DELIVERY CATHETER
Received Jul 18, 2002 · Event occurred Jul 11, 2002
Report 1062385-2002-00027 · MDR key 407806
Device
Generic name
Catheter
Manufacturer
Novoste Corp.Model number
P00563Catalog number
ABR-0340
Lot number
523909
Product problems
- Detachment Of Device Component
Patient
Not reported
- Foreign body, removal of
Narrative
Description of Event or Problem
COMPLAINANT REPORTED TIP OF BETA-RAIL CATHETER DETACHED FROM THE CATHETER MAIN BODY. THE CATHETER AND TIP WERE REMOVED FROM THE PATIENT, WITH NO ADVESE PATIENT EVENT NOTED.