MalfunctionNQH
EDOSURE 111 PRESSURE SENSOR/DELIVERY SYSTEM
Received Oct 12, 2006 · Event occurred Sep 10, 2006
Report 3004936110-2006-00003 · MDR key 841559
Device
Generic name
Intrasac Pressure Sensor/delivery Catheter
Manufacturer
Cardiomems, Inc.Model number
NACatalog number
ADS-1001
Lot number
OML60524-01
Product problems
- Detachment Of Device Component
Patient
81 YR
- Foreign body, removal of
Narrative
Description of Event or Problem
DURING INSERTION OF THE ENDOSURE AAA PRESSURE SENSOR INTO A TORTUOUS ILIAC ARTERY, THE DELIVERY CATHETER TIP DETACHED. REMOVAL OF THE TIP WAS SUCCESSFULLY PERFORMED. THE CASE WAS COMPLETED AND THE PT WAS DISCHARGED FROM THE HOSP WITHOUT INCIDENT.