inforMED
OtherMOU

3.5F BETA-RAIL (TM) DELIVERY CATHETER

Received Apr 10, 2003 · Event occurred Mar 12, 2003

Report 1062385-2003-00007 · MDR key 453755

Device

Generic name

Catheter

Manufacturer

Novoste Corp

Model number

P01814

Catalog number

ABR-0340

Lot number

621791

Product problems

  • Kinked
  • Inaccurate Delivery

Patient

*

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

Narrative

Description of Event or Problem

MISADMINISTRATION. COMPLAINANT REPORTED THAT UPON DELIVERING 18.4GY SOURCE TRAIN TO THE LEFT CIRCUMFLEX (3.0 DIAMETER), THE 3.5F BETA-RAIL (TM) DELIVERY CATHETER KINKED RESULTING IN THE SOURCES NOT REACHING THE DESIGNATED TREATMENT SITE. THE ELAPSED TIME THE SOURCES WERE INSIDE THE VESSEL AT THE SITE WAS 12 SECONDS, RESULTING IN 6% OF 18.4 GY (EQUAL TO 1.1 GY DELIVERED TO THE PROXIMAL TREATMENT SITE).