BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1133083 · Received August 22, 2008

    Report

    Report Number
    3004939290-2008-00063
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED TO PERFORM LOT HISTORY REVIEW. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED INCIDENT IS UNKNOWN. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION OR PERFORM AS INTENDED PER IFU.

    Description of Event or Problem · 1

    A MALE WITH PRIOR HISTORY OF PCI (2006) UNDERWENT AN UNCOMPLICATED DIAGNOSTIC CATHETERIZATION PROCEDURE IN 2008 THROUGH A 6FRENCH PROCEDURAL SHEATH PLACED IN THE COMMON FEMORAL ARTERY (CFA). FOLLOWING THE DIAGNOSTIC CATHETERIZATION, ANGIOGRAPHIC ASSESSMENT OF THE CFA WAS PERFORMED TO ASSESS PATIENT'S SUITABILITY FOR USE OF A MYNX VASCULAR CLOSURE DEVICE TO ACHIEVE ACCESS SITE HEMOSTASIS. THE MYNX WAS SUCCESSFULLY DEPLOYED BY A TRAINED PHYSICIAN AND IMMEDIATE HEMOSTASIS WAS ACHIEVED. THE PATIENT AMBULATED AND WAS DISCHARGED PER HOSPITAL PROTOCOL WITHOUT INCIDENT. TEN DAYS POST PROCEDURE, THE PATIENT RETURNED TO THE CLINIC WITH COMPLAINTS OF DISCOMFORT. A DOPPLER ULTRASOUND WAS PERFORMED AND A HEMATOMA OF AN UNREPORTED SIZE WAS DETECTED. NO TREATMENT WAS ADMINISTERED AT THAT TIME. PATIENT RETURNED A SECOND TIME WITHIN THE SAME DAY TO THE HOSPITAL DUE TO EXTRAVASATION FROM THE ACCESS SITE. A CT ANGIO AND ULTRASOUND CONFIRMED THE PRESENCE OF A PSEUDOANEURYSM AND A FILLING DEFECT IN ARTERY, HOWEVER, THERE WAS CONTINUED FLOW TO THE FOOT. A VASCULAR SURGEON WAS CONSULTED AND A JUMP BYPASS GRAFT AROUND THE CFA WAS USED TO REPAIR BLEEDING FROM THE VESSEL. THE WHITE BLOOD CELL COUNT WAS REPORTED AS RARE AND CULTURED TISSUE AT 24 HOURS WAS NEGATIVE FOR INFECTION. THERE ARE NO REPORTS THAT THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. PRIOR TO DISCHARGE, THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF RBC DUE TO A HEMATOCRIT DROP BELOW 12. PATIENT WAS DISCHARGED AND NO OTHER FOLLOW-UP INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R