MalfunctionNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Jun 14, 2007 · Event occurred May 18, 2007
Report 3004936110-2007-00006 · MDR key 865886
Device
Product problems
- Disengaged
- Kinked
- Device, removal of (non-implant)
Patient
74 YR
- Dural Tear
- Surgical procedure
- Foreign body, removal of
Narrative
Description of Event or Problem
THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT DUE TO SEVERE KINKING OF THE TETHER BY THE PHYSICIAN. AFTER REMOVING THE DELIVERY SYSTEM, IT WAS NOTED THAT THE SENSOR HAD BEEN RELEASED AND WAS LEFT IN THE ILIAC ARTERY. THE SENSOR WAS REMOVED WHICH CREATED A SMALL TEAR IN THE ILIAC. THE TEAR AS REPAIRED AND THE PATIENT WAS DISCHARGED WITH NO ISSUES.