BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F

    MDR report key: 2822175 · Received April 24, 2012

    Report

    Report Number
    3004939290-2012-00089
    Event Type
    Injury
    Date Received
    April 24, 2012
    Date of Event
    March 22, 2012
    Report Date
    March 27, 2012
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. THE REVIEW OF THE LHR (LOT F1133405) INDICATED THAT THE DEVICE LOT MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A "THIN" FEMALE PATIENT UNDERWENT A CATHETERIZATION PROCEDURE ON (B)(6) 2012. ACCESS WAS OBTAINED VIA A 6F SHEATH (UNKNOWN MODEL). FOLLOWING THE PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, SELECTED THE MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F TO CLOSE THE ACCESS SITE. ALLEGEDLY, A HEMATOMA DESCRIBED AS THE SIZE OF A TENNIS BALL (>6CM) DEVELOPED AT THE ACCESS SITE. THE HEMATOMA WAS RESOLVED WITH 20 MINUTES OF MANUAL COMPRESSION. THE PATIENT WAS REPORTED AS FINE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX CADENCE VASCULAR CLOSURE DEVICE 6/7F MGB ACCESSCLOSURE, INC. MX6701 F1133405

    Patients

    Seq Age Sex Outcome Treatment
    1 Other