BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1033776 · Received April 25, 2008

    Report

    Report Number
    3004939290-2008-00027
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    March 19, 2008
    Report Date
    April 23, 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 TO ACI FOR EVALUATION AND THE DEVICE'S LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE PSEUDOANEURYSM COULD NOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATIONS OR PERFORM AS INTENDED PER IFU. IN CONSIDERING POTENTIAL CAUSES, VESSEL WALL DISRUPTION MAY HAVE OCCURRED DURING EITHER OF THE PROCEDURES (2008) WITH ANY COMBINATION OF THE INITIAL STICK, PLACEMENT, REMOVAL, OR MANIPULATION OF THE PROCEDURAL CATHETER, AND/OR PLACEMENT OF THE MYNX CATHETER AND/OR BALLOON FOR EXTRAVASCULAR SEALANT PLACEMENT.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AN UNCOMPLICATED DIAGNOSTIC CATH IN 2008 WHICH DEMONSTRATED 2-VESSEL CAD. THE PHYSICIAN PROCEEDED TO USE THE MYNX DEVICE (RIGHT GROIN ACCESS SITE) IN WHICH HEMOSTASIS WAS ACHIEVED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED THE SAME DAY. THE PATIENT RETURNED ON TWO DAYS LATER FOR CORONARY INTERVENTION. PERI-PROCEDURAL HEPARIN WAS ADMINISTERED. THE PHYSICIAN RE-ACCESSED THE RIGHT GROIN, AND THE PATIENT WAS SENT TO RECOVERY WITH THE SHEATH WAS SUTURED IN. THE SHEATH WAS LATER PULLED AND MANUAL COMPRESSION WAS APPLIED. APPROXIMATELY 2 WEEKS LATER, THE PATIENT HAD COMPLAINTS OF FIRMNESS IN THE RIGHT GROIN, AND WAS ADMITTED WITH WHAT WAS REPORTED AS A RUPTURED PSEUDOANEURYSM. THE PATIENT WAS GIVEN A BLOOD TRANSFUSION, AND WAS REPORTEDLY DOING BETTER. UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO GATHER ANY ADDITIONAL INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention