InjuryNQH
ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM
Received Jun 22, 2006 · Event occurred May 24, 2006
Report 3004936110-2006-00002 · MDR key 728835
Device
Generic name
Intrasac Pressure Sensor/delivery Cath
Manufacturer
Cardiomems, Inc.Model number
NACatalog number
ADS-1001
Lot number
01D015723
Product problems
- Sticking
Patient
78 YR
- Foreign body, removal of
- Surgical procedure, additional
Narrative
Description of Event or Problem
PHYSICIAN DEPLOYED THE ENDOSURE SENSOR TOO HIGH IN THE AAA SAC. THE PHYSICIAN COULD NOT REACH THE SENSOR TO PULL IT INTO A SHEATH FOR REMOVAL. WHILE MANIPULATING THE SHEATH, THE SENSOR GOT CAUGHT ON THE FIXATION ANCHORS OF THE GORE STENT GRAFT, WHICH PREVENTED THE STENT GRAFT FROM BEING POSITIONED PROPERLY. THE PATIENT WAS CONVERTED TO AN OPEN REPAIR PROCEDURE, THE SENSOR WAS REMOVED AND THE PT WAS DISCHARGED WITHOUT FURTHER INCIDENT.