InjuryNQH
CARDIOMEMS ENDOSURE DELIVERY SYSTEM
Received Mar 29, 2007 · Event occurred Mar 19, 2007
Report 3004936110-2007-00003 · MDR key 833779
Device
Generic name
Intravascular Pressure Sensor
Manufacturer
Cardiomems, Inc.Model number
*Catalog number
ADS-1001
Lot number
*
Product problems
- Kinked
- Device, removal of (non-implant)
Patient
78 YR
- Dural Tear
- Surgical procedure, additional
Narrative
Description of Event or Problem
PT HAD VERY TORTUOUS ILIACS. SENSOR DELIVERY SYSTEM WAS INTRODUCED AND DID NOT MEET ANY RESISTANCE BUT THE DELIVERY SYSTEM SHEATH KINKED CAUSING THE GUIDEWIRE NOT TO BE ABLE TO MOVE. THE ENTIRE SYSTEM WAS REMOVED AND UPON INSPECTION THE DELIVERY SYSTEM LOOKED KINKED. AN INSPECTION WITH FLUOROSCOPY WAS PERFORMED AND IT WAS DETERMINED THAT THE ILIAC WAS TORN SO THAT REPAIR WAS NEEDED. DUE TO TORTUOSITY, THE PT REQUIRED AN OPEN REPAIR. THE PT WAS DISCHARGED WITHOUT FURTHER INCIDENT.