BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM

    MDR report key: 3221546 · Received July 1, 2013

    Report

    Report Number
    2020394-2013-00191
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR REVIEW COULD NOT BE CONDUCTED AS THE INVESTIGATION LOT NUMBER IS UNK. THE SAMPLE WAS NOT RETURNED. ONE IMAGE WAS PROVIDED AND REVIEWED. BASED UPON THE IMAGE REVIEW, THE COMPLAINT INVESTIGATION IS CONFIRMED FOR ONE BROKEN ARM (W/SHOULDER ANCHOR). BASED UPON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT (FILTER LIMB DETACHMENT) IS UNK. THE DEFINITIVE ROOT CAUSE FOR THE REPORTED REMOVAL DIFFICULTIES IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SCHEDULED VENA CAVA FILTER RETRIEVAL, A DETACHED FILTER ARM WAS DISCOVERED. THE FILTER WAS SUCCESSFULLY RETRIEVED; HOWEVER, THE DETACHED FILTER ARM REMAINS EMBEDDED IN THE IVC WALL. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297435 MERIDIAN FILTER SYSTEM DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1