inforMED
InjuryNQH

CARDIOMEMS ENDOSURE DELIVERY SYSTEM

Received Mar 30, 2007 · Event occurred Mar 14, 2007

Report 3004936110-2007-00004 · MDR key 836827

Device

Generic name

Intravascular Pressure Sensor

Manufacturer

Cardiomems, Inc.

Model number

*

Catalog number

ADS-1001

Lot number

*

Product problems

  • Device, or device fragments remain in patient
  • Difficult to Remove
  • Component Missing
  • Physical Resistance

Patient

83 YR

  • Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

THE ILIAC WAS VERY DISEASED AND TORTUOUS. THE PHYSICIAN HAD TO BALLOON TO PLACE AN 18F SHEATH. THE SENSOR DELIVERY SYSTEM WAS THEN INTRODUCED. WHILE RETRACTING THE DELIVERY SYSTEM SOME RESISTANCE WAS MET. AFTER THE DELIVERY SYSTEM WAS REMOVED, IT WAS NOTED THAT THE DILATOR TIP WAS MISSING. THE DILATOR TIP, ALTHOUGH ON THE GUIDEWIRE, WAS UNABLE TO BE RECAPTURED. THE DILATOR TIP WAS LEFT IN THE EXCLUDED ANEURYSM SAC PARALLEL TO THE STENT GRAFT. THE PATIENT WAS RELEASED FROM THE HOSPITAL WITH NO FURTHER INCIDENT.