OtherNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Sep 20, 2007 · Event occurred Sep 14, 2007
Report 3004936110-2007-00015 · MDR key 921713
Device
Product problems
- Difficult or Delayed Positioning
- Device, removal of (non-implant)
- Malposition of Device
Patient
51 YR
- Surgery, prolonged
Narrative
Description of Event or Problem
SENSOR WAS INADVERTENTLY PLACED ABOVE THE STENT GRAFT BY THE USER. THE SENSOR WOULD NOT EASILY RELEASE FROM THE DELIVERY CATHETER. EVENTUALLY THE SENSOR AND DELIVERY SYSTEM WERE REMOVED BUT THIS PROLONGED THE PROCEDURE.