BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 2072566 · Received April 21, 2011

    Report

    Report Number
    2020394-2011-00092
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K073090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. 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. THERE IS NOTHING SEEN IN THE DHR TO INDICATE THAT THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE COMPLAINT SAMPLE WAS DISCARDED BY THE USER FACILITY. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESISTANCE WAS ENCOUNTERED WITH AN IVC FILTER DELIVERY SYSTEM AND THE FILTER COULD NOT BE DEPLOYED OUT OF THE DISTAL TIP OF THE SHEATH. IT WAS THEN OBSERVED ON IMAGINE THAT ONLY THE ARMS WERE OUTSIDE OF THE SHEATH AND THE PUSHER PAD APPEARED TO BE NEXT TO THE FILTER APEX, AS OPPOSED TO UNDERNEATH IT. ADDITIONAL ACCESS WAS MADE IN THE RIGHT INTERNAL JUGULAR VEIN AND A RECOVERY CONE RETRIEVAL SYSTEM WAS USED TO REMOVE THE FILTER FROM THE PATIENT WITHOUT INCIDENT. A SECOND IVC FILTER WAS THEN IMPLANTED THROUGH THE SAME SHEATH IN THE FEMORAL ACCESS WITHOUT FURTHER INCIDENT. NO REPORT OF INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFUG3565

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR