inforMED
OtherMOU

3.5F BETA-RAIL (TM) DELIVERY CATHETER

Received Jun 3, 2003 · Event occurred May 8, 2003

Report 1062385-2003-00008 · MDR key 465234

Device

Generic name

Catheter

Manufacturer

Novoste Corp

Model number

P01814

Catalog number

ABR-0340

Lot number

UNK

Product problems

  • Use of Device Problem

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

COMPLAINANT WAS UNABLE TO VISUALLY CONFIRM THE PLACEMENT OF THE PROXIMAL MARKER OF THE SOURCE TRAIN, WHICH RESULTED IN A MISADMINISTRATION. PT IS CURRENTLY IN A STABLE CONDITION.