BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 2933529 · Received January 29, 2013

    Report

    Report Number
    3004939290-2013-00032
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT A CORONARY CATHETERIZATION PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PATIENT HAD A "LATE BLEED". THE PATIENT RETURNED TO THE PHYSICIAN'S OFFICE 2-3 DAYS POST PROCEDURE WITH A "LARGE" HEMATOMA (SIZE UNKNOWN). THE PATIENT WAS NOT HOSPITALIZED AND WAS REPORTED TO BE DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39296 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other