BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB, PRODUCT CODE: MGB

    MDR report key: 4276852 · Received November 18, 2014

    Report

    Report Number
    3004939290-2014-00973
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 28, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO BALLOONS LOSS OF PRESSURE EVENTS WERE REPORTED TO HAVE OCCURRED IN THE SAME PATIENT; THEREFORE, IT SHOULD BE NOTED THAT THE PROBABILITY OF TWO DEVICES FAILING IN THE SAME PATIENT DUE TO A PUNCTURE OF THE BALLOON IS HIGHLY IMPROBABLE WITHOUT AN OUTSIDE SOURCE CAUSING THE PUNCTURE. AN ATTEMPT TO INFLATE THE BALLOON FROM THE RETURNED DEVICE WITH WATER REVEALED A LEAK. VISUAL INSPECTION AT HIGH MAGNIFICATION CONFIRMED THAT THE SOURCE OF LEAK WAS A LONGITUDINAL TEAR ON THE BALLOON, APPROXIMATELY 5.5MM FROM THE BALLOON PROXIMAL TIP. THE REVIEW OF THE LHR (LOT F1416205) INDICATED THAT THE MYNX LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. SEE MDR 3004939290-2014-00972 FOR THE FIRST DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED: WE HAVE TWO MORE FAILED DEVICES AT (B)(6). THEY HELD PRESSURE (LESS THAN 30 MINUTES) AFTER BOTH BALLOONS DEFLATED. THERE WERE NO COMPLICATIONS. PROCEDURE TYPE: CORONARY. STICK LOCATION: COMMON FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745274 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB, PRODUCT CODE: MGB MGB, PRODUCT CODE: MGB MGB ACCESSCLOSURE, INC. MX6721 F1416205

    Patients

    Seq Age Sex Outcome Treatment
    1