MalfunctionMOU

30MM BETA-CATH DELIVERY CATHETER

Received Nov 8, 2001 · Event occurred Oct 9, 2001

Report 1062385-2001-00017 · MDR key 361470

Device

Generic name

Catheter

Manufacturer

Novoste Corp

Model number

510609-030

Catalog number

BCK-0130

Lot number

449919

Product problems

Displacement

Patient

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

Narrative

Description of Event or Problem

NOVOSTE REP REPORTED THAT THE PROXIMAL MARKER BAND ON THE CATHETER SHIFTED DURING THE VBT PROCEDURE (VASCULAR BRACHYTHERAPY). THE SITE CONSIDERED THE TREATMENT TO BE SUCCESSFUL.