BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 927607 · Received October 16, 2007

    Report

    Report Number
    3004939290-2007-00009
    Event Type
    Injury
    Date Received
    October 16, 2007
    Date of Event
    September 13, 2007
    Report Date
    October 16, 2007
    Manufacturer
    ACCESS CLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. THERE IS NO EVIDENCE THAT INDICATES, THE DEVICE DID NOT MEET SPECIFICATION AND THAT IT DID NOT PERFORM IN ACCORDANCE WITH ITS SPECIFICATIONS AND THE IFU. A CAUSAL ROLE FOR MYNX WAS NOT APPARENT GIVEN THAT THE DEVICE FUNCTIONED AS EXPECTED HAVING ACHIEVED HEMOSTASIS WITHOUT IMMEDIATE COMPLICATIONS.

    Description of Event or Problem · 1

    A MALE WITH UNSTABLE ANGINA STATUS POST LAD STENT, UNDERWENT AN UNCOMPLICATED CORONARY DIAGNOSTIC PROCEDURE IN 2007 LASTING APPROX 13 MIN. THE MYNX DEVICE WAS PREPPED AND REPORTEDLY USED PER IFU WITHOUT COMPLICATION. HEMOSTASIS WAS IMMEDIATELY ACHIEVED WITH NO NOTED BLEEDING OR HEMATOMA. PATIENT AMBULATED AND DISCHARGED PER STANDARD HOSPITAL PROCEDURE WITHOUT INCIDENT. ON NINE DAYS LATER, THE PATIENT RETURNED TO THE ER WITH INCREASING PAIN, TENDERNESS AND SWELLING IN THE RIGHT GROIN. HE WAS STARTED ON ANTIBIOTICS AND SENT TO SURGERY FOR EXPLORATION. AN INCISION WAS MADE OVER THE PUNCTURE WOUND, AND THE DRAINAGE IN THE CAVITY WAS CULTURED, RULING OUT INFECTION. THE CFA WAS FOUND TO BE INTACT WITH EXCELLENT PULSE AND NO ACUTE BLEEDING. THE WOUND WAS IRRIGATED, A DRAIN PLACED, AND DRESSED. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATIONS. ALL CULTURES (BLOOD, TISSUE, AND DRAINAGE) SHOWED NO ORGANISMS AND NEGATIVE FOR STAPHYLOCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESS CLOSURE, INC. MX6700 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R PLAVIX| HEPARIN| PREDNISONE| PLAVIX| FENTANYL| PERI-PROCEDURE MEDS:| PRE-PROCEDURE MEDS:| ASA| ASA