OtherMOU
GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE
Received Aug 22, 2003 · Event occurred Dec 10, 2002
Report 1651662-2003-00012 · MDR key 483426
Device
Generic name
Radiation System Cartridge
Manufacturer
Guidant Vascular InterventionModel number
1008112-0CCatalog number
NA
Lot number
NA
Product problems
- Method, improper/incorrect
- Difficult To Position
Patient
UNKNOWN
- Radiation Overdose
Narrative
Description of Event or Problem
DUE TO PLACEMENT ERRORS, THE SITE EXTENDED THE ACTIVE WIRE THREE TIMES BEFORE DELIVERING A FULL TREATMENT ON THE FOURTH ACTIVE WIRE EXTENSION. USER HAD FORGOTTEN TO ACCOUNT FOR THE 4MM MARGIN, SO ENDED UP DELIVERING A DOSAGE OF 690CGY BEFORE REMEMBERING HOW TO PLACE THE WIRE CORRECTLY. THEY THEN DELIVERED THE FULL TREATMENT OF 2000CGY IN ADDITION TO THE 690CGY.
Remedial action
- Relabeling