BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2170693 · Received July 21, 2011

    Report

    Report Number
    3004939290-2011-00158
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. THE REVIEW OF THE LHR (LOT F1032113) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ACI SALES PROFESSIONAL THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY (CFA) VIA A 5F PROCEDURAL SHEATH. THERE WAS NO REPORT OF FEMORAL ANGIOGRAM TO ASSESS THE SUITABILITY OF CLOSURE. POST PROCEDURE, THE PHYSICIAN WHO IS A TRAINED USER OF THE MYNX, CHOSE THE DEVICE TO CLOSE THE ACCESS SITE. IT WAS REPORTED THAT DURING PULLBACK TO THE ARTERIOTOMY, A BALLOON LOSS OF PRESSURE OCCURRED. ANOTHER MYNX, OPENED AND PREPPED WITH 50/50 CONTRAST WAS DEPLOYED. SUCCESSFUL HEMOSTASIS WAS ACHIEVED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MGB MGB ACCESSCLOSURE, INC. MX5001 F1032113

    Patients

    Seq Age Sex Outcome Treatment
    1