BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 3930931 · Received July 13, 2014

    Report

    Report Number
    3004939290-2014-00092
    Event Type
    Injury
    Date Received
    July 13, 2014
    Date of Event
    June 27, 2014
    Report Date
    June 27, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1410701) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE PATIENT UNDERWENT AN INTERVENTIONAL PERIPHERAL PROCEDURE ON (B)(6) 2014. THE STICK LOCATION WAS AT THE COMMON FEMORAL ARTERY. THE VESSEL SIZE WAS NOTED TO BE 6 MM. FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS TRAINING TO THE ACI DEVICE, SELECTED A MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT POST DEPLOYMENT, TWO MINUTES OF PRESSURE WERE HELD BUT THERE WAS STILL A TRACT OOZE. TEN ADDITIONAL MINUTES OF PRESSURE WERE APPLIED AND THEN THE PATIENT WAS MOVED OFF THE TABLE AT WHICH TIME IT WAS NOTED THAT THE SITE LOOKED "OK." ONCE THE PATIENT WAS IN THE HOLDING AREA, FIFTEEN MINUTES OF MANUAL PRESSURE WERE APPLIED AND LATER DURING THE DAY APPROXIMATELY ONE ADDITIONAL HOUR. THE PATIENT COMPLAINED OF PAIN AND A 10 CM IN DIAMETER HEMATOMA HAD FORMED WHICH ALSO FILLED THE PATIENT'S SCROTUM. THE PATIENT WAS THEN TRANSFERRED TO THE HOSPITAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. NOTE: THE PHYSICIAN CLARIFIED THAT THE PATIENT DID NOT HAVE A RETROPERITONEAL BLEED, THE PATIENT HAD A SCROTAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408998 MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6740 F1410701

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R