BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE

    MDR report key: 3900870 · Received June 27, 2014

    Report

    Report Number
    3004939290-2014-00070
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 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) MALE PATIENT UNDERWENT AN INTERVENTIONAL CORONARY PROCEDURE ON (B)(6) 2014. ACCESS WAS OBTAINED AT THE LEFT 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 DEVICE WAS DEPLOYED "PERFECTLY" BY THE PHYSICIAN. IMMEDIATELY AFTER REMOVAL OF THE DEVICE, THE GROIN BEGAN TO SWELL WITH CONSTANT OOZING. THE HEMATOMA GREW TO 5 CM. MANUAL PRESSURE WAS APPLIED TO THE GROIN FOR AN ADDITIONAL HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376541 MYNX ACE 6F/7F VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6740 F1410703

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention