BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN FILTER SYSTEM- JUGULAR

    MDR report key: 3221549 · Received July 1, 2013

    Report

    Report Number
    2020394-2013-00192
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K102511
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MFG PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MFG RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS FAILURE MODE. THE FILTER WAS RETURNED AND THE COMPLICATION INVESTIGATION IS CONFIRMED FOR A FILTER ARM DETACHMENT (W/SHOULDER ANCHOR). BASED ON THE IMAGE REVIEW THE FILTER CAN BE CONFIRMED FOR A MERIDIAN FILTER, FROM THE ANCHORS DEMONSTRATED. ADDITIONALLY, A DETACHED LIMB CAN BE CONFIRMED BASED ON THE IMAGE FROM THE FILTER RETRIEVAL PROCEDURE. HOWEVER, BASED UPON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT 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 AND THE DETACHED ARM WERE SUCCESSFULLY RETRIEVED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297556 MERIDIAN FILTER SYSTEM- JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFWD2827

    Patients

    Seq Age Sex Outcome Treatment
    1