BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F

    MDR report key: 3083377 · Received April 29, 2013

    Report

    Report Number
    3004939290-2013-00107
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE REVIEW OF THE LHR (LOT F1302201) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    THE ACI SALES PROFESSIONAL REPORTED THAT A MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2013. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F SHEATH (MODEL UNKNOWN). PERI-PROCEDURE, THE PATIENT WAS ANTI-COAGULATED WITH ANGIOMAX. A PRE-PROCEDURE FEMORAL ANGIOGRAM REVEALED "MINIMAL" PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE AND THE VESSEL SIZE TO BE 7MM. FOLLOWING THE PROCEDURE, THE TECHNICIAN WHO IS A TRAINED USER, SELECTED THE MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT THE BALLOON RUPTURED DURING PULL BACK AND THE SHEATH CAME OUT OF THE ACCESS SITE. THE PATIENT WAS CONVERTED TO 15 MINUTES OF MANUAL COMPRESSION. THEN A FEMOSTOP WAS APPLIED AT THE ACCESS SITE FOR APPROXIMATELY 2 HOURS, AT WHICH TIME HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS HOSPITALIZED FOR REASONS UNRELATED TO THE MYNX DEVICE/MYNX PROCEDURE. THE PATIENT'S DISCHARGE DATE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185579 MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F MGB MGB ACCESSCLOSURE, INC. MX6721 F1302201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ANGIOMAX