BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE FILTER SYSTEM - FEMORAL

    MDR report key: 2011909 · Received February 14, 2011

    Report

    Report Number
    2020394-2011-00030
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K093659
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 MFG 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 MFG RELATED CAUSE FOR THIS EVENT. THE FILTER REMAINS IMPLANTED. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON DEPLOYMENT, THE LEGS OF AN IVC FILTER WERE TWISTED AROUND ONE ANOTHER AND THE FILTER FAILED TO COMPLETELY OPEN. REPORTEDLY, THE FILTER WAS PARTIALLY ADVANCED OUT OF THE DELIVERY SYSTEM PRIOR TO CONFIRMING THE PLACEMENT LOCATION. THE FILTER WAS THEN PULLED BACK INTO THE DELIVERY SYSTEM THEN DEPLOYED. AN ATTEMPT TO RETRIEVE THE FILTER WAS NOT PERFORMED. AN ADD'L FILTER WAS IMPLANTED ABOVE THE PREVIOUS FILTER. 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. GFUC2324

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR