BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 1901163 · Received November 10, 2010

    Report

    Report Number
    2020394-2010-00327
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    May 20, 2010
    Report Date
    October 18, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER. THE FILTER REMAINS IMPLANTED. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SCHEDULED RETRIEVAL ATTEMPT, IT WAS IDENTIFIED THAT THE IVC FILTER, IMPLANTED FIVE MONTHS AGO, WAS TILTED APPROXIMATELY 45 DEGREES AND THE APEX WAS EMBEDDED IN THE CAVA WALL. THE RETRIEVAL ATTEMPT WAS UNSUCCESSFUL. SUBSEQUENTLY, A CT DEMONSTRATED THAT ONE FILTER LIMB WAS OUTSIDE OF THE CAVA WALL BY 4-5 MM. NO DYE EXTRAVASATION WAS NOTED. THE PT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFUA4097

    Patients

    Seq Age Sex Outcome Treatment
    1 COUMADIN