BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 2841354 · Received October 23, 2012

    Report

    Report Number
    2020394-2012-00234
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 2012
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED FILTER RETRIEVAL FLUOROSCOPY DEMONSTRATED THE APEX OF THE FILTER WAS EMBEDDED IN THE IVC WALL AND TWO LIMBS HAD PERFORATED THE IVC WALL. A RECOVERY CONE AND A SNARE WERE BOTH UNSUCCESSFUL IN AN ATTEMPT TO RETRIEVE THE FILTER; THEREFORE, A RAT TOOTH CLAMP WAS USED TO REMOVE THE FILTER SUCCESSFULLY. A FILTER LIMB FRACTURED DURING THE RETRIEVAL AND COULD NOT BE REMOVED AS IT WAS EMBEDDED IN THE IVC WALL. A POST IVC FILTER REMOVAL ANGIOGRAM DEMONSTRATED NO ACTIVE BLEEDING IN THE IVC FROM THE TWO LEGS THAT PERFORATED THE WALL PRIOR TO REMOVAL. NO REPORTED PATIENT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1