BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM - FEMORAL

    MDR report key: 2994074 · Received February 27, 2013

    Report

    Report Number
    2994074
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 27, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT CAME TO THE INTERVENTIONAL RADIOLOGY DEPARTMENT FOR THE REMOVAL OF AN INFERIOR VENA CAVA (IVC) FILTER. ON A SCOUT FILM, IT WAS NOTED THAT ONE OF THE FILTER LEGS WAS DETACHED/FRACTURED AND EMBEDDED IN THE CAVAL WALL ON THE RIGHT SIDE. USING A SNARE DEVICE, THE INDWELLING IVC FILTER WAS RETRIEVED SUCCESSFULLY. THE DETACHED/FRACTURED LEG WAS LEFT IN THE PATIENT. THE PATIENT WAS REFERRED TO A VASCULAR SURGEON FOR TREATMENT OPTIONS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IVC FILTER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83820 MERIDIAN FILTER SYSTEM - FEMORAL FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BARD PERIPHERAL VASCULAR, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR NO