MalfunctionNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Dec 17, 2008 · Event occurred Nov 19, 2008
Report 3004936110-2008-00008 · MDR key 1321709
Device
Product problems
- Difficult To Position
Patient
69 YR
- No Information
Narrative
Description of Event or Problem
A BUDDY WIRE WAS USED DURING THE INSERTION OF THE STENT GRAFT AND SENSOR. WHILE REMOVING THE GUIDE CATHETER, THE BUDDY WIRE WAS ACCIDENTALLY WITHDRAWN. UPON REINSERTION THE BUDDY WIRE WAS LOCATED INSIDE OF THE STENT GRAFT RESULTING IN RELEASE OF THE SENSOR BY THE PHYSICIAN WITHIN THE STENT GRAFT AFTER THE ANEURYSM WAS SEALED. A SNARE WAS INSERTED AND THE SENSOR WAS REMOVED FROM THE PATIENT. NO ADDITIONAL SENSOR WAS PLACED.