BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECOVERY G2 FILTER SYSTEM, FEMORAL

    MDR report key: 886263 · Received July 27, 2007

    Report

    Report Number
    2020394-2007-00225
    Event Type
    Malfunction
    Date Received
    July 27, 2007
    Date of Event
    June 27, 2007
    Report Date
    June 28, 2007
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DHR WAS REVIEWED AND CONFIRMED THAT THE LOT MET RELEASE CRITERIA. ONE FEMORAL DELIVERY SYSTEM WAS RECEIVED FOR EVALUATION. THERE WAS NO INTRODUCER SHEATH OR DILATOR RETURNED. UPON INSPECTION OF THE RETURNED SAMPLE, THE DELIVERY SYSTEM WAS RETURNED ASSEMBLED TOGETHER WITH THE FILTER PROTRUDING OUT OF THE STORAGE TUBE. THE LEGS OF THE FILTER APPEARED TO BE CAUGHT IN THE END OF THE STORAGE TUBE. THE TOUHY NUT WAS TIGHT. THE PUSHER PAD OF THE PUSHERWIRE WAS NOT SET IN THE APEX OF THE FILTER, AS IT WAS ON THE OUTSIDE OF THE ARMS OF THE FILTER. UNDER MAGNIFICATION, IT APPEARED THAT 1 LEG OF THE FILTER WAS NOT SET IN THE GROOVE OF THE TIGHT SPLINE. THE SPLINE APPEARED TO BE SLIGHTLY DAMAGED. ONE CORNER, ON ONE OF THE SPLINE GROOVES APPEARED TO ROUNDED AND PUSHED IN. THE DAMAGE TO THE SPLINE MAY HAVE OCCURED FROM THE BINDING OF THE DISLODGED FILTER LEG BETWEEN THE TIGHT SPLINE AND THE ID OF THE STORAGE TUBE. THE ID OF THE STORAGE TUBE EXHIBITED SOME SCRATCH MARKS THAT IMPLY THAT THE FILTER MAY HAVE BEEN STOPPED, TWISTED, PULLED BACK AND THEN ATTEMPTED TO MOVE FORWARD AGAIN. HEAT WAS APPLIED TO THE FILTER AND THE FILTER TOOK SHAPE. ALL ARMS, LEGS AND HOOKS WERE PRESENT AND INTACT. THE FILTER, PUSHER WIRE, AND STORAGE TUBE ID WERE MEASURED AND ALL MEASUREMENTS TAKEN WERE WITHIN SPECIFICATIONS. THE RESULT OF THE INVESTIGATION WAS CONFIRMED FOR FAILURE TO DEPLOY AS THE FILTER WAS RECEIVED STILL PARTIALLY IN THE TUBE, ROOT CAUSE UNKNOWN. IT IS UNKNOWN IF PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. THE CURRENT IFU, (INFORMATION 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 IFU (INFORMATION 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 THAT THE PHYSICIAN WAS ABLE TO ADVANCE THE FILTER INTO THE DELIVERY SHEATH, BUT THEN UNABLE TO ADVANCE FURTHER. HE WAS ABLE TO WITHDRAW THE FILTER FROM THE SHEATH AND PLACE A NEW ONE THROUGH THE SHEATH WHICH WAS ALREADY IN PLACE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVERY G2 FILTER SYSTEM, FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFRF0055

    Patients

    Seq Age Sex Outcome Treatment
    1 YR