BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 2223607 · Received August 25, 2011

    Report

    Report Number
    3004939290-2011-00192
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND THE PROCEDURAL SHEATH WERE NOT RETURNED; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INFORMATION PROVIDED AND NO RETURNED DEVICE FOR PHYSICAL INVESTIGATION, THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE CAUSE COULD NOT BE DETERMINED. THE REVIEW OF THE LHR (LOT F1025904) INDICATED THAT THE MYNX DEVICE MET ALL ESTABLISHED PERFORMANCE CRITERIA PRIOR TO SHIPMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE (B)(6) THAT A PATIENT UNDERWENT A DIAGNOSTIC CORONARY CATHETERIZATION PROCEDURE ON (B)(6) 2011, IN WHICH A MYNX DEVICE WAS USED FOR FEMORAL ARTERIAL CLOSURE. ACCESS WAS OBTAINED AT THE COMMON FEMORAL ARTERY VIA A 6F PROCEDURAL SHEATH. A PRE-PROCEDURAL FEMORAL ANGIOGRAM WAS TAKEN WHICH REVEALED PRESENCE OF CALCIUM AT THE VICINITY OF THE ARTERIOTOMY. POST PROCEDURE, THE PHYSICIAN WHO IS IN TRAINING ON THE MYNX, WITH A (B)(6) PRESENT, CHOSE THE DEVICE TO CLOSE THE FEMORAL ARTERY. IT WAS REPORTED THAT WHILE THE PHYSICIAN WAS PULLING THE BALLOON BACK TOWARDS THE ARTERIOTOMY, A BALLOON RUPTURE OCCURRED. THE DEVICE WAS REMOVED AND THE PATIENT WAS CONVERTED TO MANUAL COMPRESSION WHERE A SUCCESSFUL HEMOSTASIS WAS ACHIEVED. THE PATIENT WAS AMBULATED AND DISCHARGED WITHOUT REPORT OF CLINICAL SEQUELA. 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. MX6700 F1025904

    Patients

    Seq Age Sex Outcome Treatment
    1