OtherMOU
GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE
Received Aug 22, 2003 · Event occurred Jun 20, 2002
Report 1651662-2003-00010 · MDR key 483415
Device
Generic name
Radiation System Cartridge
Manufacturer
Guidant Vascular InterventionModel number
1008114-0CCatalog number
NA
Lot number
NA
Product problems
- Displacement
- Method, improper/incorrect
Patient
UNKNOWN
- Radiation Overdose
Narrative
Description of Event or Problem
THE SITE WAS PERFORMING A TANDEM TREATMENT. THE PROXIMAL REFERENCE LUMEN DIAMETER (RLD) WAS DETERMINED TO BE 3.3 MM AND THE DISTAL RLD WAS DETERMINED TO BE 2.8 MM. THE PROXIMAL SEGMENT WAS TREATED SUCCESSFULLY. THE RLD VALUE FOR THE DISTAL SEGMENT WAS MISTAKENLY ENTERED AS 3.3 MM RATHER THAN 2.8 MM AS WAS MEASURED. THE SITE INVESTIGATED THE POSSIBLE MISADMINISTRATION WITH THE DEPTH DOSE TABLES PROVIDED IN THE GALILEO INSTRUCTIONS FOR USE. THE SITE CALCULATED THE DOSE DELIVERED TO BE 26.4GY.
Remedial action
- Other