HYPERFOAM OCCLUSION BALLOON SYSTEM
Received Aug 6, 2009 · Event occurred Aug 5, 2009
Report MW5012316 · MDR key 1436247
Product problems
- Detachment Of Device Component
- Material Rupture
Patient
67 YR
- Death
- Hemorrhage/Blood Loss/Bleeding
- Rupture
Narrative
Description of Event or Problem
THE PATIENT WAS BROUGHT THROUGH THE ED. A HEAD CT SCAN WAS PERFORMED AND INTERVENTIONAL COILING WAS ATTEMPTED. DURING THE PROCEDURE, AFTER DEPLOYING COILS, DR TRIED TO ACCESS THE PCA VESSEL TO TRY AND PLACE A STENT ACROSS THE ANEURYSM, BUT WAS UNSUCCESSFUL. HE THEN INSERTED AN OCCLUSION BALLOON (HYPERFORM OCCLUSION BALLOON SYSTEM LOT# 684114 MADE BY EV3: 7MM BALLOON DIAMETER, 7MM BALLOON LENGTH. DR WAS ABLE TO INFLATE THE BALLOON AND WAS UNSUCCESSFUL DEFLATING THE BALLOON. EVENTUALLY, WHILE TRYING TO REMOVE/DEFLATE THE BALLOON, THE BALLOON RUPTURED AND SEPARATED FROM ITS CATHETER. THE ANEURYSM RE-RUPTURED. PT CTB AT 1035 IN 2009.