OtherMOU
ALPHA IV REV.2,40MM ACTIVE TRANSFER DEVICE
Received Dec 11, 2002 · Event occurred Nov 1, 2002
Report 1062385-2002-00042 · MDR key 432630
Device
Generic name
Transfer Device
Manufacturer
Novoste CorporationModel number
A1733Catalog number
WLC-0001-033
Lot number
NA
Product problems
- Other (for use when an appropriate device code cannot be identified)
- Inaccurate Delivery
Patient
*
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
COMPLAINANT REPORTED A MISADMINISTRATION INVOLVING THE 40MM SOURCE TRAIN. DURING THE TREATMENT, THE DOCTOR NOTICED MOVEMENT OF THE DISTAL MARKER THAT COULD POSSIBLY RESULT IN SOURCE MOVEMENT. AT THAT TIME, THE DOCTOR DECIDED TO REMOVE THE ENTIRE BETA-CATH SYSTEM FROM THE PT AND PLACED IN THE BAIL OUT BOX AT 2 MINUTES AND 24 SECONDS INTO THE TREATMENT. THE PT WAS SURVEYED IMMEDIATELY AND NO ADVERSE EVENT WAS REPORTED. THIS RESULTED IN A DELIVERED DOSE OF -29% FROM THE PRESCRIBED DOSE VALUE.