BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1771025 · Received July 27, 2010

    Report

    Report Number
    3004939290-2010-00079
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 26, 2010
    Report Date
    June 28, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. BASED ON THE LIMITED PROCEDURE AND PATIENT INFORMATION PROVIDED, THE CAUSE OF THE REPORTED LOCAL REACTION COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE MYNX DEVICE DID NOT MEET SPECIFICATION. THE MYNX IS TERMINALLY STERILIZED AND SUBJECTED TO LAL (LIMULUS AMEBOCYTE LYSATE) TESTING TO ENSURE THE PRODUCT MEETS STERILIZATION AND BACTERIAL ENDOTOXIN REQUIREMENTS PRIOR TO EACH LOT BEING RELEASED FOR COMMERCIAL USE. ADDITIONALLY THE IFU STATES: THE FOLLOWING ADVERSE REACTIONS OR CONDITIONS MAY ALSO BE ASSOCIATED WITH MYNX OR WITH THE DIAGNOSTIC OR INTERVENTIONAL PROCEDURE: ALLERGIC REACTION, FOREIGN BODY REACTION, INFECTION, INFLAMMATION, OR VESSEL LACERATION. THE REVIEW OF THE LHR (LOT # F1009804) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE ACI SALES PROFESSIONAL ON (B)(4) 2010 THAT A MALE PATIENT UNDERWENT A DIAGNOSTIC HEART CATHETERIZATION PROCEDURE ON (B)(6) 2010. FOLLOWING THE PROCEDURE, MYNX WAS CHOSEN AND USED FOR FEMORAL ARTERIAL CLOSURE. THERE WERE NO REPORTED COMPLICATIONS DURING THE PROCEDURE OR CLOSURE. THE PATIENT WAS AMBULATED AND DISCHARGED PER HOSPITAL PROTOCOL. FIVE DAYS POST PROCEDURE, ON (B)(6) 2010, THE PATIENT PHONED THE PHYSICIAN COMPLAINING OF "PAIN AND SWELLING IN THE GROIN AND LEG." THE PATIENT WAS ASKED TO RETURN TO THE PHYSICIAN ON (B)(6) 2010 WHERE THE PHYSICIAN READMITTED THE PATIENT AND PUT THE PATIENT ON A COURSE OF BENADRYL AND STEROIDS GIVEN INTRAVENOUSLY. ON (B)(6) 2010, THE PATIENT REMAINED HOSPITALIZED BUT A CT SCAN AND ULTRASOUND WERE NEGATIVE FOR ANY ARTERIAL DISTURBANCE OR HEMATOMA. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED THAT SAME DAY ((B)(6) 2010) WITH NO FURTHER CLINICAL SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1009804

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention