MalfunctionMOU
BETA - CATH UNIT
Received Oct 17, 2003 · Event occurred Sep 18, 2003
Report MW1029890 · MDR key 492833
Product problems
- Difficult To Position
Patient
82 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
MD FELT CATHETER NEEDED TO BE REPOSITIONED SLIGHTLY & SOURCES RETURNED TO THE BETA-CATH APPLICATOR. SOURCES WERE NOT RETURNED WITHIN 5 SECONDS. MD HAD REPOSITIONED CATHETER & THE SOURCES WERE RETURNED TO THE STENT & IRRADIATION OF THE VESSELS WAS COMPLETED W/DIFFICULTY. FULL ASSESSMENT OF CATHETER MADE BY APPROPRIATE PERSONNEL TO DETERMINE CAUSE OF DYSFUNCTION. PROCEDURE COMPLETED W/O DIFFICULTY & NO EXCESSIVE EXPOSURE TO PT OR STAFF.