BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNXGRIP

    MDR report key: 11640555 · Received April 9, 2021

    Report

    Report Number
    11640555
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 9, 2021
    Report Date
    March 25, 2021
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PROCEDURE COMPLETED: PHYSICIAN WAS DEPLOYING VASCULAR CLOSURE DEVICE. UPON REMOVAL, THE BALLOON WOULD NOT DEFLATE, SO COULD NOT REMOVE FROM DELIVERY SYSTEM. ON THIRD ATTEMPT, BALLOON WAS ABLE TO BE REMOVED BY TECHNICIAN HOLDING THE BALLOON SYRINGE IN THE DEFLATION MODE, WHILE PHYSICIAN REMOVED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536886 MYNXGRIP DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE, INC. MX5021 F2021602

    Patients

    Seq Age Sex Outcome Treatment
    1 16790 DA