BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYNX VASCULAR CLOSURE DEVICE

    MDR report key: 1121204 · Received August 14, 2008

    Report

    Report Number
    3004939290-2008-00066
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ACCESSCLOSURE, INC.
    Product Code
    MGB
    PMA / PMN Number
    P040044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: BALLOON SEPARATION FROM THE MYNX DEVICE WAS CONFIRMED. THE RECOVERED BALLOON WAS SENT TO ACCESSCLOSURE, INC. FOR INVESTIGATION AND IT WAS NOTED THAT THE STOPCOCK WAS STILL IN THE CLOSED POSITION, INDICATING A HIGH PROBABILITY THAT THE BALLOON HAD NOT BEEN DEFLATED PRIOR TO DEVICE REMOVAL, AS MANDATED IN THE IFU. BASED ON THE INVESTIGATION PERFORMED, THE REPORTED INCIDENT (BALLOON DETACHMENT) WAS DUE TO EXCESSIVE TENSION APPLIED TO THE DEVICE DURING CATHETER WITHDRAWAL THROUGH THE ADVANCER TUBE WHEN THE BALLOON WAS FULLY INFLATED. THE IFU INSTRUCTS THE USER TO; "OPEN STOPCOCK AND LOCK SYRINGE TO DEFLATE BALLOON TO MAX NEGATIVE, TO ENSURE COMPLETE BALLOON DEFLATION, WAIT UNTIL AIR BUBBLES AND FLUID HAVE STOPPED MOVING THROUGH THE INFLATION TUBING, LIGHTLY GRASP ADVANCER TUBE AT SKIN WITH THUMB AND FOREFINGER, AND REALIGN WITH THE TISSUE TRACT, APPLY LIGHT FINGERTIP COMPRESSION AND SLOWLY WITHDRAW BALLOON CATHETER THROUGH THE ADVANCER TUBE LUMEN. NOTE: IF UNUSUAL RESISTANCE IS FELT DURING CATHETER WITHDRAWAL, PULL THE ADVANCER TUBE AND BALLOON CATHETER TOGETHER THROUGH THE TISSUE TRACT."

    Description of Event or Problem · 1

    A PATIENT UNDERWENT AN UNCOMPLICATED DIAGNOSTIC CATHETERIZATION IN 2008 IN WHICH A 6F SHEATH WAS USED TO ACCESS THE CFA. THE PHYSICIAN PROCEEDED TO USE MYNX VASCULAR CLOSURE DEVICE TO ACHIEVE ACCESS SITE HEMOSTASIS. THE MYNX DEVICE WAS REPORTEDLY PREPPED PER IFU AND DEPLOYED BY A TRAINED OPERATOR. THE OPERATOR WAS SUCCESSFUL IN DELIVERING THE SEALANT. HOWEVER, WHILE ATTEMPTING TO REMOVE THE DEVICE THROUGH THE ADVANCER TUBE, RESISTANCE WAS FELT. THE OPERATOR SUCCESSFULLY RETRACTED THE ADVANCER TUBE AND REMOVED THE DEVICE. IT WAS THEN NOTED THAT THE BALLOON WAS PARTIALLY SEPARATED FROM THE CATHETER. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED WITH MYNX AND DISTAL PULSES WERE REPORTEDLY NORMAL AT TIME OF DISCHARGE. THE PATIENT RETURNED FOR FOLLOW-UP, AND THERE ARE NO CLINICAL SEQUELAE TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYNX VASCULAR CLOSURE DEVICE MYNX MGB ACCESSCLOSURE, INC. MX6700 F0815802

    Patients

    Seq Age Sex Outcome Treatment
    1