MalfunctionNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Dec 3, 2008 · Event occurred Aug 13, 2007
Report 3004936110-2007-00013 · MDR key 1301718
Device
Product problems
- Break
- Detachment Of Device Component
- Difficult to Insert
Patient
79 YR
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PATIENT HAD VERY TIGHT CALCIFIED ILIAC ARTERIES. THE SENSOR WAS INSERTED AND WOULD NOT ADVANCE COMPLETELY THROUGH THE SHEATH. WHEN TRYING TO ADVANCE FOR A THIRD TIME, THE SHEATH WAS PULLED BACK AND THE CATHETER WAS BROKEN, LEAVING THE SENSOR AND DISTAL END OF THE CATHETER IN THE ARTERY. A RIGHT COMMON ILIAC CUT DOWN WAS PERFORMED TO REMOVE THE SENSOR AND DISTAL END OF THE CATHETER. ANOTHER SENSOR WAS NOT ATTEMPTED. ENDARTERECTOMIES WERE PERFORMED ON BOTH SIDES TO PLACE THE STENT GRAFT. THE OVERALL PROCEDURE WAS SUCCESSFUL.