BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX CADENCE

    MDR report key: 2880884 · Received December 6, 2012

    Report

    Report Number
    2880884
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 12, 2012
    Report Date
    December 4, 2012
    Manufacturer
    ACCESS CLOSURE
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    MYNX DEVICE WAS OPENED TO THE STERILE FIELD AND BURST (THE BALLOON EXPANDED BUT THE DEVICE DID NOT DEPLOY). A SECOND MYNX CLOSURE DEVICE WAS OPENED AND THE SAME THING OCCURRED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE DEVICE, HEMOSTASIS, VASCULAR MGB ACCESS CLOSURE * F1224806

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO OTHER THERAPIES