CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received May 10, 2008 · Event occurred Apr 17, 2008
Report 3004936110-2008-00002 · MDR key 1041380
Device
Product problems
- Device, or device fragments remain in patient
- Difficult to Remove
Patient
74 YR
- Nonresorbable materials, unretrieved in body
Narrative
Description of Event or Problem
THE PHYSICIAN HAD DIFFICULTY ADVANCING THE DELIVERY SYSTEM WITH SENSOR INTO ANEURYSM SAC. THE PHYSICIAN ELECTED TO REMOVE THE DELIVERY SYSTEM WITH SENSOR VIA A 14FR SHEATH. DURING REMOVAL, THE SENSOR WAS UNTETHERED FROM THE DELIVERY SYSTEM AND REMAINED INSIDE THE 14FR SHEATH. DURING SHEATH EXCHANGE, THE SENSOR REMAINED IN THE ILIAC ARTERY. A SNARE WAS USED TO TRY TO RETRIEVE THE SENSOR BUT WAS UNSUCCESSFUL. THE SENSOR WAS THEN PUSHED PROXIMAL TO THE ANEURYSM SAC. ADDITIONAL ATTEMPTS WERE MADE TO RETRIEVE THE SENSOR WITH THE SNARE BUT THESE WERE UNSUCCESSFUL. A LATERAL IMAGE OF THE SENSOR WAS TAKEN WHICH CONFIRMED THAT THE SENSOR WAS LOCATED IN THE ANEURYSM SAC. THE SENSOR REMAINED IN THE ANEURYSM SAC AND THE PROCEDURE CONTINUED WITHOUT ANY ADDITIONAL ISSUES.