GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE
Received Apr 21, 2004 · Event occurred Dec 2, 2003
Report 1651662-2004-00004 · MDR key 554040
Device
Generic name
Radiation System Cartridge
Manufacturer
Guidant, HoustonModel number
1008112-0CCatalog number
NA
Lot number
NA
Product problems
- Failure to Power Up
Patient
UNKNOWN
- Radiation Underdose
Narrative
Description of Event or Problem
THE PHYSICIST REPORTED THE FOLLOWING SCENARIO DURING A TREATMENT: THE SITE STARTED TO TREAT THE FIRST POSITION IN A TWO-POSITION TREATMENT. THE SYSTEM LOST POWER DURING THIS TREATMENT; THEREFORE, THE FIRST POSITION ONLY RECEIVED 1973 CGY DOSE. INSTEAD OF CONTINUING THIS CASE, THE ONCOLOGIST REPOSITIONED THE CATHETER TO THE SECOND POSITION AND STARTED A NEW TWO-POSITION TREATMENT. THE SECOND POSITION RECEIVED THE NORMAL 20 GY DOSE AND THEN THE SYSTEM RETRACTED TO THE THIRD POSITION AND DWELLED IN THIS THIRD POSITION FOR A COUPLE OF SECONDS BEFORE THE TREATMENT. THE SECOND POSITION RECEIVED THE NORMAL 20 GY DOSE AND THEN THE SYSTEM RETRACTED TO THE THIRD POSITION AND DWELLED IN THIS THIRD POSITION FOR A COUPLE OF SECONDS BEFORE THE TREATMENT WAS INTERRPUTED. THIS THIRD AREA RECEIVED A 56 CGY DOSE.