inforMED
MalfunctionNQH

CARDIOMEMS ENDOSURE DELIVERY SYSTEM

Received Aug 14, 2007 · Event occurred Aug 13, 2007

Report 3004936110-2007-00011 · MDR key 898078

Device

Generic name

Intravascular Pressure Sensor

Manufacturer

Cardiomems, Inc.

Catalog number

ADS-1001

Product problems

  • Detachment Of Device Component

Patient

83 YR

  • No Information

Narrative

Description of Event or Problem

DELIVERY SYSTEM WAS ADVANCED THROUGH TORTUOUS ANATOMY AND NOSE CONE DETACHED FROM DELIVERY SYSTEM. NOSE CONE REMAINED ON GUIDEWIRE AND WAS SUCCESSFULLY RETRIEVED WITH SNARE. NO SENSOR WAS IMPLANTED.