MalfunctionNQH
ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM
Received May 2, 2006 · Event occurred Apr 24, 2006
Report 3004936110-2006-00001 · MDR key 708713
Device
Generic name
Intrasac Pressure Sensor/delivery Catheter
Manufacturer
Cardiomems, Inc.Model number
NACatalog number
ADS-1001
Lot number
11C013628
Product problems
- Detachment Of Device Component
Patient
82 YR
- Foreign body, removal of
- Hospitalization required
Narrative
Description of Event or Problem
DURING INSERTION OF THE ENDOSURE AAA PRESSURE SENSOR INTO A CALCIFIED ILIAC ARTERY, THE DELIVERY CATHTER DETACHED. REMOVAL OF THE TIP WAS SUCCESSFULLY PERFORMED. THE CASE WAS COMPLETED AND THE PT WAS DISCHARGED FROM THE HOSP WITHOUT INCIDENT.