GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE
Received Aug 22, 2003 · Event occurred Mar 25, 2003
Report 1651662-2003-00013 · MDR key 483419
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
DURING A PATIENT TREATMENT USING THE GALILEO SYSTEM, IT WAS REPORTED THAT THE ACTIVE WIRE WAS PLACED 6MM PROXIMAL TO THE DISTAL CATHETER MARKER AND DWELLED FOR 17 SECONDS. THE PHYSICIAN STOPPED THE PROCEDURE DUE TO THE IMPROPER PLACEMENT OF THE WIRE. THE WIRE WAS THEN REPOSITIONED AND DWELLED FOR 13 SECONDS BEFORE BEING STOPPED AGAIN FOR IMPROPER ACTIVE WIRE PLACEMENT. THE WIRE WAS POSITIONED A THIRD TIME AND A FULL TREATMENT WAS DELIVERED WITH A DWELL OF 144 SECONDS. THE DOSE DELIVERED TO THE PORTION INCLUDED WITH THE FIRST TWO DWELLS WAS REPORTED TO BE 2833CGY.
Remedial action
- Other
- Relabeling