GALILEO INTRAVASCULAR RADIOTHERAPY CARTRIDGE, SOURCE WIRE
Received Nov 21, 2002 · Event occurred Oct 21, 2002
Report 1651662-2002-00003 · MDR key 429336
Device
Generic name
Radiation System Cartridge
Manufacturer
Guidant Vascular InterventionModel number
1010147-0ACatalog number
1010147-0A
Lot number
NA
Product problems
- Use of Device Problem
- Unknown (for use when the device problem is not known)
- Failure to Deliver
Patient
UNKNOWN
- No Consequences Or Impact To Patient
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A CALL WAS RECEIVED BY GUIDANT TECHNICAL SERVICES IN WHICH THE PHYSICIST REPORTED THAT THE SITE HAD MISTAKENLY USED PASSWORD "4444" TO ENTER TREATMENT MODE ("4444" IS THE PLACEBO TREATMENT PASSWORD USED DURING THE CLINICAL STUDIES WITHIN A CONTROL GROUP). AFTER THE TREATMENT (PLACEBO) WAS COMPLETED, THE SITE REVIEWED THE TREATMENT SUMMARY AND FOUND THAT NO DOSE HAD BEEN DELIVERED. THEY THEN ENTERED TREATMENT MODE USING THEIR PASSWORD AND SUCCESSFULLY TREATED THE PT. THE SITE PHYSICIST EXPRESSED CONCERN THAT A PREVIOUS PLACEBO TREATMENT MAY HAVE UNKNOWINGLY BEEN PERFORMED AS WELL.