BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM - FEMORAL

    MDR report key: 1945240 · Received December 10, 2010

    Report

    Report Number
    2020394-2010-00357
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS NOT KNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE FILTER WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING RETRIEVAL OF AN IVC FILTER, IT WAS OBSERVED THAT THE FILTER HAD MIGRATED CAUDALLY, WITH THE FILTER LEGS STRADDLING THE BIFURCATION. IN ADDITION, IT WAS REPORTED THAT THE FILTER WAS SIGNIFICANTLY TILTED. THE FILTER WAS SUCCESSFULLY REMOVED WITH A RECOVERY CONE. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1