BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1101123 · Received August 4, 2008

    Report

    Report Number
    3004939290-2008-00052
    Event Type
    Injury
    Date Received
    August 4, 2008
    Date of Event
    May 28, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ACCESSCLOSURE, 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 DEVICE LOT NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT IS LIKELY THE RESULT OF FAILURE TO FOLLOW GUIDELINES PROVIDED IN THE INSTRUCTIONS FOR USE; SPECIFICALLY, TO ASSESS THERE IS NO EVIDENCE OF SIGNIFICANT PVD IN THE VICINITY OF THE PUNCTURE, AND TO ENSURE THE BALLOON ABUTS THE ARTERIOTOMY SITE. 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 FEMALE PATIENT WITH LUPUS UNDERWENT AN EMERGENT PERCUTANEOUS CORONARY INTERVENTION PROCEDURE IN 2008. THE CORONARY INTERVENTION WAS PERFORMED THROUGH THE RIGHT COMMON FEMORAL ARTERY FOLLOWED BY CLOSURE WITH THE MYNX VASCULAR CLOSURE DEVICE. DESPITE INSTRUCTIONS IN THE IFU, CONFIRMATION VIA FEMORAL ANGIOGRAM FOR PATIENT SUITABILITY WAS NOT OBTAINED PRIOR TO MYNX DEPLOYMENT. IT WAS ALSO REPORTED THAT THE OPERATOR MAY NOT HAVE GAINED COMPLETE TEMPORARY HEMOSTASIS DURING DEPLOYMENT. PER THE IFU, THE BALLOON SHOULD ABUT THE ARTERIOTOMY PRIOR TO SEALANT DEPLOYMENT IN ORDER TO GAIN TEMPORARY HEMOSTASIS. ACCESS SITE HEMOSTASIS WAS REPORTED TO BE SUCCESSFUL AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT INCIDENT. FIVE DAYS POST PROCEDURE, THE PATIENT COMPLAINED OF HER RIGHT LEG BEING COLD AND PALE. DOPPLER ULTRASOUND DEMONSTRATED A RIGHT SFA OCCLUSION. SURGICAL REVASCULARIZATION WAS SUCCESSFUL AND SHE TOLERATED THE PROCEDURE WELL. A POST PROCEDURE PATHOLOGY REPORT INDICATES AN ORGANIZED FIBRINOID MATERIAL ASSOCIATED WITH POLARIZABLE FOREIGN MATTER AND BLOOD COAGULUM WAS REMOVED.

    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 39 YR Hospitalization| R