BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP (5F) VASCULAR CLOSURE DEVICE

    MDR report key: 5167223 · Received October 21, 2015

    Report

    Report Number
    3004939290-2015-00489
    Event Type
    Malfunction
    Date Received
    October 21, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 9, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AND INSPECTED BY ACCESSCLOSURE, INC. (A CARDINAL HEALTH COMPANY). VISUAL INSPECTION OF THE DEVICE SHOWED THAT THE SHUTTLE CARTRIDGE WAS DISENGAGED FROM THE HANDLE. THE SEALANT WAS BUNCHED UP AND PROTRUDING FROM THE SHUTTLE CARTRIDGE NEAR THE BALLOON'S PROXIMAL BOND. THE ADVANCER TUBE WAS FOUND INSIDE THE SHUTTLE CARTRIDGE AND PROPERLY ENGAGED TO THE PROXIMAL TAMP LOCK. THE SHUTTLE CARTRIDGE MOVED FREELY ON THE CATHETER SHAFT DURING THE INVESTIGATION. THE BALLOON WAS INFLATED WITH WATER AND PRESSURE WAS MAINTAINED AND THE INFLATION INDICATOR PERFORMED PER SPECIFICATION. THE PROCEDURAL SHEATH WAS NOT RETURNED; THEREFORE, A COMPLETE PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE PROVIDED INFORMATION AND THE INVESTIGATION PERFORMED, THE PROBABLE CAUSE FOR THE FAILURE TO DEPLOY COULD NOT BE CONCLUSIVELY DETERMINED. THE REVIEW OF THE LHR (F1522205) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: THE DEPLOYMENT FAILED. MANUAL PRESSURE WAS HELD FOR 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696352 MYNXGRIP (5F) VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX5021 F1522205

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR