inforMED
MalfunctionMOU

40 MM BETA-CATH DELIVERY CATHETER

Received Nov 20, 2002 · Event occurred Dec 7, 2001

Report 1062385-2002-00016 · MDR key 429601

Device

Generic name

Catheter

Manufacturer

Novoste Corp.

Model number

510609-040

Catalog number

BCK-0140

Lot number

444148

Product problems

  • Sticking

Patient

*

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

COMPLAINANT INITIALLY REPORTED THAT SOURCE TRAIN STUCK ON/AT THE MARKER BAND. INITIAL EVALUATION BY NOVOSTE DETERMINED THAT THE PROXIMAL MARKER BAND ON THE CATHETER MOVED.