BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE

    MDR report key: 3900873 · Received June 27, 2014

    Report

    Report Number
    3004939290-2014-00074
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 10, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE REVIEW OF THE LHR (LOT F1411307) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2014. ACCESS WAS OBTAINED AT THE SUPERFICIAL FEMORAL ARTERY. THE VESSEL SIZE WAS NOTED TO BE >6 MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS TRAINING TO THE ACI DEVICE, SELECTED A MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE PATIENT HAD A PSEUDOANEURYSM THE NEXT MORNING WHICH WAS CONFIRMED BY ULTRASOUND. A FEMOSTOP WAS PLACED. IT WAS CONFIRMED BY ULTRASOUND THAT THE PSEUDOANEURYSM HAD BEEN RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014. THE PATIENT'S HOSPITALIZATION WAS UNRELATED TO THE MYNX DEVICE/MYNX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376542 MYNXGRIP (6F/7F) VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6721 F1411307

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R