BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 5182157 · Received October 27, 2015

    Report

    Report Number
    3004939290-2015-00496
    Event Type
    Injury
    Date Received
    October 27, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 13, 2015
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED. NOTE: PI NUMBER IS UNKNOWN AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS REPORTED: VERY FLUENT MYNXGRIP VASCULAR CLOSURE DEVICE USER FAILED TO ACHIEVE HEMOSTASIS WITH THE DEVICE. SPECIFICALLY, UPON DEVICE REMOVAL FROM THE PATIENT THERE WAS IMMEDIATELY BLEEDING AT THE SKIN LEVEL AS WELL AS UNDER THE SKIN THAT RESULTED IN A HEMATOMA OF OVER 6 CM IN SIZE WHICH WAS MANAGED BY THE PHYSICIAN AND THE RADIOLOGIC TECHNOLOGIST. HEMOSTASIS WAS ACHIEVED AFTER 22 MINUTES MANUAL COMPRESSION WITH NO FURTHER COMPLICATIONS. IT IS UNKNOWN IF THE PATIENT WAS HOSPITALIZED. PROCEDURE TYPE: INTERVENTION PERIPHERAL SHEATH SIZE: 7F.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710177 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB CARDINAL HEALTH MX6721 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other