BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 4192516 · Received October 22, 2014

    Report

    Report Number
    3004939290-2014-00614
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TWO BALLOON LOSS OF PRESSURE EVENTS WERE REPORTED TO HAVE OCCURRED IN THE SAME PATIENT. HOWEVER, THE DEVICES WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. 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. THE REVIEW OF THE LHR (LOT F1422404) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. (B)(4). SEE MDR REPORT # 3004939290-2014-00615 FOR THE SECOND DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: BALLOON POPPED DURING PULLBACK ON 2 DEVICES SAME PATIENT. MANUAL COMPRESSION WAS APPLIED FOR 30 MINUTES OR LESS. THE PATIENT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672359 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 F1422404

    Patients

    Seq Age Sex Outcome Treatment
    1