BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1170463 · Received September 11, 2008

    Report

    Report Number
    2020394-2008-00259
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. THE SAMPLE HAS NOT BEEN RETURNED FOR EVAL TO DATE. BASED ON THE INFO RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT INFO FOR USE (IFU) FOR THIS DEVICE STATES THE FOLLOWING PRECAUTIONS: DO NOT DELIVER THE FILTER BY PUSHING IT BEYOND THE END OF THE INTRODUCER CATHETER. TO ACHIEVE PROPER PLACEMENT, UNSHEATH THE STATIONARY FILTER BY WITHDRAWING THE INTRODUCER CATHETER. DO NOT TWIST THE PUSHER WIRE HANDLE AT ANY TIME DURING THIS PROCEDURE. WARNINGS: DELIVERY OF THE G2 FILTER THROUGH THE INTRODUCER CATHETER IS ADVANCE ONLY. RETRACTION OF THE PUSHER WIRE DURING DELIVERY COULD RESULT IN DISLODGEMENT OF THE FILTER, CROSSING OF FILTER LEGS OR ARMS, AND COULD PREVENT THE FILTER FROM FURTHER ADVANCEMENT WITHIN THE INTRODUCER CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENA CAVA FILTER DID NOT DEPLOY. THE PHYSICIAN USED ANOTHER VENA CAVA FILTER FOR A SUCCESSFUL OUTCOME AND NO HARM TO THE PT.

    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