BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS ENDOSURE DELIVERY SYSTEM

    MDR report key: 1041380 · Received May 10, 2008

    Report

    Report Number
    3004936110-2008-00002
    Event Type
    Malfunction
    Date Received
    May 10, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 24, 2008
    Manufacturer
    CARDIOMEMS, INC.
    Product Code
    NQH
    PMA / PMN Number
    K070680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN HAD DIFFICULTY ADVANCING THE DELIVERY SYSTEM WITH SENSOR INTO ANEURYSM SAC. THE PHYSICIAN ELECTED TO REMOVE THE DELIVERY SYSTEM WITH SENSOR VIA A 14FR SHEATH. DURING REMOVAL, THE SENSOR WAS UNTETHERED FROM THE DELIVERY SYSTEM AND REMAINED INSIDE THE 14FR SHEATH. DURING SHEATH EXCHANGE, THE SENSOR REMAINED IN THE ILIAC ARTERY. A SNARE WAS USED TO TRY TO RETRIEVE THE SENSOR BUT WAS UNSUCCESSFUL. THE SENSOR WAS THEN PUSHED PROXIMAL TO THE ANEURYSM SAC. ADDITIONAL ATTEMPTS WERE MADE TO RETRIEVE THE SENSOR WITH THE SNARE BUT THESE WERE UNSUCCESSFUL. A LATERAL IMAGE OF THE SENSOR WAS TAKEN WHICH CONFIRMED THAT THE SENSOR WAS LOCATED IN THE ANEURYSM SAC. THE SENSOR REMAINED IN THE ANEURYSM SAC AND THE PROCEDURE CONTINUED WITHOUT ANY ADDITIONAL ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOMEMS ENDOSURE DELIVERY SYSTEM INTRAVASCULAR PRESSURE SENSOR NQH CARDIOMEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention