BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 7116488 · Received December 14, 2017

    Report

    Report Number
    7116488
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    December 2, 2017
    Report Date
    December 7, 2017
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT INTO ER DUE TO PAIN AND COOLNESS IN RIGHT FOOT. HISTORY OF RECENT LOWER EXTREMITY ANGIOGRAM TO CHECK BYPASS GRAFT AND FOOT HAS HURT SINCE. CUTDOWN WITH THROMBECTOMY PERFORMED. DURING PROCEDURE, ON-CALL ENDOVASCULAR SURGEON USED A FOGERTY CATHETER AND REMOVED WHAT IS BELIEVED TO BE THE BALLOON OF A MYNX CLOSURE DEVICE THAT HAD BEEN PUT IN EARLIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896886 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE, INC. MX5021 F1719804

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR