BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1894514 · Received November 9, 2010

    Report

    Report Number
    3004939290-2010-00121
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 PATIENT AND PROCEDURE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED HEMATOMA AND PSEUDOANEURYSM COULD NOT BE CONCLUSIVELY DETERMINED. THE PROCEDURE WAS A RIGHT AND LEFT HEART CATHETERIZATION, HOWEVER NO INFORMATION WAS PROVIDED IN REGARDS TO THE VENOUS ACCESS. IT IS UNKNOWN IF THE REPORTED HEMATOMA AND PSEUDOANEURYSM WERE ARTERIAL OR VENOUS. IN ADDITION, IT WAS REPORTED THAT THE PATIENT WAS STARTED ON COUMADIN (EXACT TIMEFRAME UNKNOWN) AND HER INTERNATIONAL NORMALIZED RATIO (INR) WAS REPORTED TO BE OVER 8.0. PER THE MYNX INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF MYNX HAVE NOT BEEN ESTABLISHED IN PATIENTS WITH DOCUMENTED INR > 1.5. ALSO, HEMATOMA AND PSEUDOANEURYSM ARE ANTICIPATED COMPLICATIONS OF CATHETERIZATION PROCEDURES, REGARDLESS OF THE USE OF CLOSURE DEVICES. THEY CAN ALSO OCCUR WITH MANUAL COMPRESSION. THE REVIEW OF THE LHR (LOT # F1020301) 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 THAT A FEMALE PATIENT (B)(6) WITH A HISTORY OF HYPERTENSION UNDERWENT A DIAGNOSTIC LEFT AND RIGHT HEART CATHETERIZATION (L/RHC) PROCEDURE ON (B)(6) 2010, TO ASSESS HER FOR VALVE SURGERY. A 6F SHEATH WAS USED TO ACCESS THE RIGHT FEMORAL ARTERY WITH NO ANTICOAGULANT ON BOARD. POST PROCEDURE, A FEMORAL ANGIOGRAM SHOWED THE VESSEL APPEARED TO BE OF NORMAL SIZE AND MORPHOLOGY. AFTER THE PROCEDURE, THE MYNX DEVICE WAS USED FOR ARTERIAL CLOSURE. IT WAS REPORTED THAT THE DEPLOYMENT WAS NORMAL AND HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH THE MYNX. THE NEXT DAY, THE PATIENT UNDERWENT VALVE SURGERY AND WAS DISCHARGED AFTER A STANDARD 5-DAY RECOVERY. A FEW DAYS LATER, THE PATIENT PRESENTED AT A DIFFERENT HOSPITAL'S EMERGENCY ROOM (ER). AN ULTRASOUND CONFIRMED A PSEUDOANEURYSM (PSA) AND SHE WAS SENT TO SURGERY FOR HEMATOMA EVACUATION AS WELL AS REPAIR OF THE PSA. IT WAS REPORTED THAT SHE HAS RECOVERED FINE FROM THE SURGERY HOWEVER, THERE IS NO INFORMATION PROVIDED REGARDING DISCHARGE. NOTE: IT WAS REPORTED THAT THE PATIENT WAS STARTED ON COUMADIN PRIOR TO THE VALVE SURGERY AND LATER HER INTERNATIONAL NORMALIZED RATIO (INR) WAS TESTED AND WAS REPORTED TO BE OVER 8.0. THE PATIENT IS STILL HYPERTENSIVE, BUT IT IS BEING CONTROLLED BY MEDICATION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX6700 F1020301

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention