BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX

    MDR report key: 2853103 · Received July 2, 2012

    Report

    Report Number
    3004939290-2012-00207
    Event Type
    Injury
    Date Received
    July 2, 2012
    Date of Event
    June 8, 2012
    Report Date
    June 15, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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, THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. A REVIEW OF THE LHR WAS NOT POSSIBLE, AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI VASCULAR CLOSURE SPECIALIST THAT AN "OBESE FEMALE PATIENT, WITH DIABETES, UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2012. A PRE-PROCEDURE FEMORAL ANGIOGRAM SHOWED NO PRESENCE OF PVD/CALCIUM IN THE VICINITY OF THE ACCESS SITE, AND THE VESSEL SIZE TO BE APPROXIMATELY 7 MM. ACCESS WAS OBTAINED AT THE RIGHT COMMON FEMORAL ARTERY, VIA A 6F SHEATH (MODEL UNK). FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO WAS IN TRAINING, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT ONE WEEK AFTER THE PROCEDURE, THE PATIENT WOKE UP WITH OOZING AT THE ACCESS SITE. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2012, AND WAS TREATED FOR A 2-3 INCH HEMATOMA. THE PHYSICIAN APPLIED PRESSURE FOR 10 MINUTES, IN WHICH THE HEMATOMA WAS PRESSED OUT. THE PATIENT WAS KEPT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX MGB ACCESSCLOSURE, INC. MX6701 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention