MalfunctionMOU
NOVOSTE BETA-CATH IVB
Received Jun 12, 2013 · Event occurred Jun 3, 2013
Report 3208703 · MDR key 3208703
Device
Generic name
Device, Intravascular Brachytherapy
Manufacturer
Best Vascular, IncModel number
NOVOSTE 40 MMCatalog number
*
Lot number
*
Product problems
- Entrapment of Device
Patient
*
- No Code Available
Narrative
Description of Event or Problem
WHEN THE SYSTEM WAS ENGAGED TO RETURN THE RADIATION SOURCES, THE SOURCES DID NOT IMMEDIATELY RETURN AS EXPECTED. THE SOURCES WERE STUCK IN THE AREA OF THE AORTA. THERE WAS AN APPROXIMATELY A 1 MINUTE DELAY WHILE THE ENTIRE SYSTEM WAS REMOVED TO PREVENT CONTINUED EXPOSURE.THIS HAS HAPPENED BEFORE WITH THE DEVICE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VASCULAR BRACHYTHERAPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.