BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1020663 · Received March 27, 2008

    Report

    Report Number
    3004939290-2008-00019
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 23, 2008
    Report Date
    March 26, 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 DEVICE'S LOT NUMBER WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. THERE IS NO EVIDENCE THAT INDICATES THE DEVICE DID NOT MEET SPECIFICATION AND THAT IT DID NOT PERFORM IN ACCORDANCE WITH ITS SPECIFICATIONS AND THE IFU. BASED ON THE INFORMATION PROVIDED AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE OF THE REPORTED ABSCESS COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AN UNCOMPLICATED CORONARY INTERVENTION PROCEDURE IN 2008, IN WHICH THE MYNX DEVICE WAS USED TO ACHIEVE HEMOSTASIS WITHOUT COMPLICATION. APPROXIMATELY 3 WEEKS POST MYNX PROCEDURE, THE PATIENT PRESENTED WITH A REPORTED RIGHT GROIN ABSCESS AT THE ACCESS SITE. ADDITIONAL PATIENT AND MYNX PROCEDURAL INFORMATION WAS REQUESTED, HOWEVER, NOT OBTAINED. THE FOLLOWING MONTH, THE PATIENT WAS SENT TO THE OPERATING ROOM WHERE AN INCISION WAS MADE OVER THE SITE AND THE WOUND WAS IRRIGATED AND INSPECTED. ACCORDING TO THE SURGEON, THE SITE DID NOT APPEAR INFECTED, AND NO PURULENT DRAINAGE WAS OBSERVED WHEN PRESSURE WAS APPLIED, THUS FURTHER DEBRIDEMENT WAS NOT INDICATED. GAUZE WAS PLACED, STERILE DRESSING APPLIED, AND THE PATIENT WAS TRANSFERRED TO RECOVERY IN STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL AND WITHOUT FURTHER COMPLICATION. WOUND CULTURE DOCUMENTED MODERATE STAPH AUREUS.

    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 Required Intervention