inforMED
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

NA

Catalog 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.