BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 3930944 · Received July 13, 2014

    Report

    Report Number
    3004939290-2014-00091
    Event Type
    Injury
    Date Received
    July 13, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON AN UNKNOWN DATE. FOLLOWING THE PROCEDURE, THE PHYSICIAN SELECTED A MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE DEPLOYMENT WAS FINE BUT THE PATIENT DEVELOPED A HEMATOMA (SIZE UNKNOWN). MANUAL COMPRESSION WAS APPLIED FOR MORE THAN 30 MINUTES. THE PATIENT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409029 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R