BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1013953 · Received March 14, 2008

    Report

    Report Number
    3004939290-2008-00016
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 14, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND THE LOT NUMBER WAS NOT PROVIDED FOR LOT HISTORY REVIEW. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED INCIDENT COULD NOT BE DETERMINED. NO OTHER INFORMATION, INDICATING THAT THE DEVICE DID NOT PERFORM AS INTENDED, HAS BEEN PROVIDED. THE EXCISED MATERIAL WAS NOT SENT TO PATHOLOGY. THEREFORE THE IDENTIFICATION OF THE MATERIAL IS UNDETERMINED.

    Description of Event or Problem · 1

    A FEMALE PATIENT REPORTEDLY UNDERWENT AN UNCOMPLICATED CORONARY INTERVENTION IN 2008. THE PHYSICIAN, TRAINED TO THE MYNX PROCEDURE, REPORTEDLY USED THE MYNX DEVICE PER IFU, AND HEMOSTASIS WAS ACHIEVED WITHOUT COMPLICATION. THE PATIENT RETURNED TO THE HOSPITAL ON TEN DAYS LATER, FOR REPEAT CATHETERIZATION DUE TO CONTINUED CHEST PAIN. FEMORAL ANGIOGRAM WAS ASSESSED PRIOR TO CLOSURE WHICH DEMONSTRATED A MOBILE LUCENCY IN THE AREA OF THE PREVIOUS MYNX SITE. THE PATIENT WAS ASYMPTOMATIC, HOWEVER, THE PHYSICIAN RECOMMENDED EXPLORATION AND EXTRACTION DUE TO THE POTENTIAL RISK OF FUTURE EMBOLIZATION AND ISCHEMIA. DURING THE SURGICAL PROCEDURE, THE CURRENT SHEATH WAS REMOVED AS WELL AS THE REPORTED ABNORMALITY SEEN ON THE ANGIO. THE PROCEDURE LASTED APPROXIMATELY 25 MINUTES AND WAS REPORTEDLY PERFORMED WITHOUT COMPLICATION. THE PATIENT WAS DISCHARGED THE NEXT DAY, WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX VASCULAR CLOSURE DEVICE MGB ACCESSCLOSURE, INC. MX6700 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention MEDICATIONS INCLUDED PLAVIX| COUMADIN.