inforMED
MalfunctionNQH

ENDOSURE S2 PRESSURE MEASUREMENT SYSTEM

Received Jun 8, 2009 · Event occurred May 14, 2009

Report 3004936110-2009-00002 · MDR key 1466095

Device

Generic name

Intravascular Pressure Sensor

Manufacturer

Cardiomems, Inc.

Catalog number

S2-2080

Product problems

  • Separation Failure

Patient

82 YR

  • Blood Loss

Narrative

Description of Event or Problem

SENSOR DELIVERED WITHOUT ISSUE. SENSOR WAS UNABLE TO BE RELEASE FROM THE DELIVERY SYSTEM. SENSOR WAS REMOVED FROM THE PATIENT WITH SOME BLOOD LOSS. NO ADDITIONAL SENSOR WAS PLACED.