BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY G2 FILTER SYSTEM, FEMORAL

    MDR report key: 885174 · Received July 23, 2007

    Report

    Report Number
    2020394-2007-00220
    Event Type
    Malfunction
    Date Received
    July 23, 2007
    Date of Event
    June 22, 2007
    Report Date
    June 29, 2007
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS THIS PRODUCT IS THE SAME OR SIMILAR TO A PRODUCT SOLD IN THE US, CATALOG NUMBER RF310F, 510K#K062887. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNK. THE SAMPLE WAS NOT RETURNED FOR EVALUATION TO DATE. BASED ON THE INFO SUBMITTED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. THE CURRENT IFU (INFO FOR USE) STATES THE FOLLOWING: 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: THE CURRENT IFR (INFO FOR USE) STATES THE FOLLOWING: DELIVERY OF THE G2 FILTER THROUGH THE INTRODUCER CATHETER IS ADVANCE ONLY. RETRACTION OF THE PUSHER WIRE DURING DELIVERY COULD RESULT IN DISLODGMENT 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 THE DOCTOR ATTEMPTED DEPLOYMENT. THE FILTER WAS POSITIONED 2CM BELOW THE LOWEST RENAL VIA THE FEMORAL APPROACH, BUT WOULD ONLY PARTIALLY DEPLOY. THE WHOLE UNIT WAS THEN EXTRACTED FROM THE PT VIA THE FEMORAL AND ANOTHER FILTER WAS USED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR