MalfunctionMOU
ALPHA IV REV.2, 30MM ACTIVE TRANSFER DEVICE
Received Aug 7, 2002 · Event occurred Aug 2, 2002
Report 1062385-2002-00032 · MDR key 410342
Device
Generic name
Transfer Device
Manufacturer
Novoste CorporationModel number
A1732Catalog number
WLC-001-032
Lot number
NA
Product problems
- Replace
- Device Issue
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINANT REPORTED THAT DURING PROCEDURE, THEY HAD DIFFICULTY WITH THE DUMMY RUN ON THE 30MM TRANSFER DEVICE AND COULD NOT COMPLETE THE RUN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 40MM TRANSFER DEVICE INSTEAD. AT THE TIME, COMPLAINANT COULD NOT POSITIVELY IDENTIFY ALL THE RADIOACTIVE SOURCES. NOVOSTE CORPORATION WAS CONTACTED AND ALL RADIOACTIVE SOURCES WERE POSITIVELY ACCOUNTED FOR. THERE WAS NO PATIENT ADVERSE EVENT NOTED.