BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 3994024 · Received August 6, 2014

    Report

    Report Number
    3994024
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 6, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN ATTEMPTED TO INSERT A 6F/7F MYNX CLOSURE DEVICE. THE BALLOON RUPTURED WHEN HE TRIED TO DEPLOY. HE WAS ABLE TO REMOVE AND PLACED A DIFFERENT MYNX DEVICE IN THE SAME SITE WITHOUT DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459613 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESSCLOSURE, INC. 6F/7F F1412801

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR THIS COULD POSSIBLY BE A PHYSICIAN TRAINING ISSUE.| HAD PROBLEMS WITH IT."| IT WAS STATED TO ME THAT "ONLY THIS PHYSICIAN HAS