BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN FILTER SYSTEM - JUGULAR

    MDR report key: 4381485 · Received December 31, 2014

    Report

    Report Number
    2020394-2014-00598
    Event Type
    Injury
    Date Received
    December 31, 2014
    Date of Event
    November 21, 2014
    Report Date
    December 9, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K102511
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED VIA USER FACILITY REPORT #240078-2014-00002. THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, SUBASSEMBLIES, MANUFACTURING PROCESS, AND QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR THIS LOT NUMBER AND FAILURE MODE. THE DEVICE OR IMAGES WERE RETURNED FOR EVALUATION; THEREFORE, THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS POST FILTER DEPLOYMENT FOR IVC THROMBUS, A DETACHED FILTER LEG WAS DISCOVERED IN THE LEFT VENTRICLE OF THE HEART. OPEN HEART SURGERY WAS PERFORMED TO REMOVE THE DETACHED FILTER LIMB. THE PATIENT STATUS AT THIS TIME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863922 MERIDIAN FILTER SYSTEM - JUGULAR DTK BARD PERIPHERAL VASCULAR, INC. GFXI1342

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening