BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM, JUGULAR

    MDR report key: 1132303 · Received August 22, 2008

    Report

    Report Number
    2020394-2008-00239
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 25, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K052578
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE SAMPLE REMAINS IMPLANTED, SO NO SAMPLE EVALUATION WAS PERFORMED. SIX X-RAY FILMS WERE RECEIVED AND REVIEWED. SEVERAL FILMS CONFIRMED THAT 2 LEGS WERE TWISTED/TANGLED. IT ALSO SHOWED THAT ONE FILTER ARM WAS MALPOSITIONED, POINTING DOWN AND INWARD TOWARD THE CENTER OF THE FILTER. DIFFERENT FIMS SHOWED THE FILTER LEGS AND ARMS IN DIFFERENT POSITIONS. IT COULD NOT BE DETERMINED WHAT AFFECT MANIPULATION MAY HAVE HAD ON THE FILTER POSITION. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR 2 TWISTED LEGS BASED ON THE X-RAY REVIEW. THE ROOT CAUSE IS UNKNOWN. THE CURRENT INFORMATION FOR USE (IFU) STATES: PRECAUTIONS: IF MISPLACEMENT OR SUB-OPTIMAL PLACEMENT OF THE FILTER OCCURS, CONSIDER IMMEDIATE REMOVAL. RETRIEVE THE G2 FILTER USING THE RECOVERY CONE REMOVAL SYSTEM ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY POST DEPLOYMENT OF A JUGULAR G2 FILTER, IT WAS NOTICED THAT TWO OF THE LIMBS WERE CROSSED. THE PHYSICIAN REPORTED THAT HE USED PROPER TECHNIQUE. THE PHYSICIAN DECIDED TO LEAVE THE FILTER IN PLACE. NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM, JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFSE2024

    Patients

    Seq Age Sex Outcome Treatment
    1