BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FEMOSTOP

    MDR report key: 1822131 · Received August 20, 2010

    Report

    Report Number
    1822131
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 20, 2010
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    DXC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN RECOVERY FOLLOWING A HEART CATH PROCEDURE. AT THE END OF THE PROCEDURE PATIENT DEVELOPED A HEMATOMA SO STAFF WAS USING THE FEMOSTOP TO MANAGE THE HEMATOMA. THE FEMOSTOP WAS IN THE CORRECT POSITION ON THE LEFT GROIN. THE FEMOSTOP TUBING WAS CLAMPED, BUT THE MANOMETER INDICATED A SLOW LEAK (NOT AUDIBLE) AS THE PRESSURE IN MMHG WOULD CONTINUALLY AND SLOWLY DECREASE. THE DEVICE WAS REMOVED AND REPLACED WITH A SECOND FEMOSTOP WHICH WORKED CORRECTLY, MAINTAINED PRESSURE AS NEEDED, AND HEMOSTASIS WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMOSTOP CLAMP, VASCULAR DXC ST JUDE MEDICAL * 102657

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR