BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 3911246 · Received July 2, 2014

    Report

    Report Number
    3004939290-2014-00078
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 F1410703) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (B)(6) YEAR OLD, MALE PATIENT UNDERWENT A DIAGNOSTIC CORONARY PROCEDURE ON (B)(6) 2014. THE STICK LOCATION WAS AT THE RIGHT FEMORAL ARTERY. THE VESSEL SIZE WAS NOTED TO BE 5 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 THE PATIENT HAD THIN LEGS AND PART OF THE SEALANT WAS EXPOSED. THE PHYSICIAN HYDRATED AND CUT THE EXCESS SEALANT AT THE SKIN LEVEL. THEN, TUCKED AND BANDAGED THE SEALANT. SEVERAL HOURS AFTER THE CLOSURE, WHILE THE PATIENT WAS IN RECOVERY, THE PATIENT DEVELOPED A FIST-SIZED HEMATOMA (APPROXIMATELY 5 CM X 5 CM). MANUAL COMPRESSION WAS APPLIED FOR 60 MINUTES. THE PATIENT WAS HOSPITALIZED FOR REASONS UNRELATED TO THE MYNX DEVICE / MYNX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385934 MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6740 F1410703

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention