MalfunctionNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Jul 23, 2007 · Event occurred Jun 12, 2007
Report 3004936110-2007-00009 · MDR key 886246
Device
Product problems
- Detachment Of Device Component
- Kinked
- Replace
- Device, removal of (non-implant)
Patient
83 YR
- Foreign body, removal of
Narrative
Description of Event or Problem
THE PATIENT HAD TORTUOUS ILIACS AND SEVERE CALCIFICATION AT THE BIFURCATION. THE FIRST DELIVERY SYSTEM WAS KINKED BEFORE ENTERING THE BODY BY THE SCRUB TECH. THE SECOND DEVICE WAS DELIVERED WITH NO PROBLEMS. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE BODY, IT WAS NOTED THAT THE NOSE CONE TIP HAD DETACHED. THE NOSE CONE WAS RETRIEVED WITH A SNARE AND PULLED INTO A SHEATH. THE CASE ENDED WITH GOOD RESULTS AND NO ADDITIONAL PROBLEMS.