inforMED
MalfunctionMOU

3.5F BETA-RAIL DELIVERY CATHETER

Received Jul 24, 2002 · Event occurred Jul 18, 2002

Report 1062385-2002-00030 · MDR key 407788

Device

Generic name

Catheter

Manufacturer

Novoste Corp.

Model number

P00563

Catalog number

ABR-0340

Lot number

UNK

Product problems

  • Difficult to Remove
  • Sticking
  • Device Damaged Prior to Use

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

COMPLAINANT REPORTED THAT AFTER TREATMENT, THE CUSTOMER WAS RETRACTING THE 3.5F BETA-RAIL CATHETER AND IT GOT STUCK ON THE GUIDEWIRE. THE DISTAL RADIOPAQUE TIP ON THE CATHETER APPEARED TO BE DAMAGED. THE PATIENT WAS SUCCESSFULLY TREATED WITH NO PATIENT ADVERSE EVENT NOTED.