BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1024281 · Received March 27, 2008

    Report

    Report Number
    2020394-2008-00068
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. THE SAMPLE HAS BEEN RETURNED; HOWEVER, EVALUATION HAS NOT BEEN COMPLETED. BASED ON THE INFO AVAILABLE TO DATE, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THE CURRENT INFO FOR USE (IFU) FOR THIS DEVICE STATES: POTENTIAL COMPLICATIONS: FILTER FRACTURE IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN REPORTS OF EMBOLIZATION OF VENA CAVA FILTER FRAGMENTS RESULTING IN RETRIEVAL OF THE FRAGMENT USING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. MOST CASES OF FILTER FRACTURE, HOWEVER, HAVE BEEN REPORTED WITHOUT ANY ADVERSE CLINICAL SEQUELAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON RETRIEVAL OF AN IVC FILTER THE DOCTOR NOTICED THAT THERE WAS A BROKEN LEG. THE LEG WAS BROKEN AT THE MIDDLE AND HAD NOT MIGRATED. THE FILTER HAD BEEN IMPLANTED FOR 18 MONTHS AND IT WAS AT THE SCHEDULED RETRIEVAL THAT IT WAS NOTED ONE OF THE COMPONENTS HAD FRACTURED. IT WAS NOTED APPROXIMATELY 3 MONTHS AFTER THE FILTER WAS IMPLANTED THAT IT HAD TILTED, TO WHAT DEGREE IS UNKNOWN. THE PATIENT HAD MULTIPLE PICC'S BUT NO CENTRAL LINE. THE BROKEN LEG FRAGMENT APPEARED FULLY EMBEDDED IN THE CAVAL WALL AND WAS NOT REMOVED. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1