BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 EXPRESS FILTER SYSTEM- FEMORAL

    MDR report key: 1213201 · Received October 22, 2008

    Report

    Report Number
    2020394-2008-00294
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K080668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS MANUFACTURING LOT NUMBER. THE FILTER COULD NOT BE EVALUATED, AS IT REMAINS IMPLANTED. AS STATED IN THE EVENT DESCRIPTION, THE PROBABLE ROOT CAUSE IS USER ERROR AND FAILURE TO FOLLOW INSTRUCTIONS IN THE IFU. HOWEVER, WITHOUT ACTUAL FILMS OF THE PROCEDURE, THIS CANNOT BE CONFIRMED. BASED ON THE INFO RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS: THE G2 EXPRESS FILTER IS PRE-LOADED INTO THE STORAGE TUBE AND IS INTENDED FOR SINGLE USE ONLY. DO NOT DEPLOY THE FILTER PRIOR TO PROPER POSITIONING IN THE IVC, AS THE G2 EXPRESS FILTER CANNOT BE SAFELY RELOADED INTO THE STORAGE TUBE. DO NOT DEPLOY THE FILTER UNLESS IVC HAS BEEN PROPERLY MEASURED. POSITION THE RETRIEVAL HOOK 1CM BELOW THE LOWEST RENAL VEIN. VENACAVOGRAPHY MUST ALWAYS BE PERFORMED TO CONFIRM PROPER IMPLANT SITE. RADIOGRAPHS WITHOUT CONTRAST, WHICH DO NOT CLEARLY SHOW THE WALL OF THE IVC, MAY BE MISLEADING. DELIVERY OF THE G2 EXPRESS 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 ALLEGEDLY WAS MISPLACED AND FAILED TO OPEN. THE PHYSICIAN USUALLY USES AN APPROACH FROM THE RIGHT BUT WAS UNABLE TO FIND THE FEMORAL ARTERY. USING AN APPROACH FROM THE LEFT SIDE, THE PHYSICIAN POSITIONED THE CATHETER AND PULLED BACK DOWN ON THE DELIVERY SYSTEM. THE ENTIRE SYSTEM ALLEGEDLY MOVED AND THE FILTER DEPLOYED INTO AN ACCESSORY VEIN. THE FILTER TILTED AND DID NOT OPEN IN THE ACCESSORY VEIN. THE PHYSICIAN STATED THAT THE MISPLACEMENT WAS HIS ERROR. WHEN HE PULLED BACK, HE SAID SHOULD HAVE PUT IN A NEW WIRE BUT DID NOT. THE PATH WAS TORTUOUS. THE PHYSICIAN THEN IMPLANTED ANOTHER VENA CAVA FILTER SUCCESSFULLY. THE APEX OF THE SECOND FILTER IS AT THE FEET OF THE FIRST FILTER. PHYSICIAN WILL LEAVE BOTH FILTERS IN PLACE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 EXPRESS FILTER SYSTEM- FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFSF0630

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR