BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM 9735542 15W VISUALASE

    MDR report key: 6869090 · Received September 15, 2017

    Report

    Report Number
    1723170-2017-03748
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    August 18, 2017
    Report Date
    October 13, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    UDI-DI
    00643169655935
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE REPRESENTATIVE REPORTED THAT THE LASER GENERATOR TESTS PASSED. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE SUSPECT FIBERS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. BOTH RETURNED FIBERS WERE FOUND TO HAVE PHYSICAL EVIDENCE OF CHARRING ON THEM. LOG ANALYSIS FOUND THAT THE LASER OUTPUT WAS AT 92% RATHER THAN THE 30% INDICATED BY THE MEDTRONIC REPRESENTATIVE. THE REPRESENTATIVE REPORTED THAT THE ENERGY WAS BEING TRANSFERRED TO THE LASER DIFFUSING FIBER (LDF) RATHER THAN TO THE ABLATION. THE ENERGY AND MATERIAL OF THE FIBER WERE FOUND TO LEAD TO THE CARBONIZATION OF THE FIBER WITHIN THE COOLING CATHETER SYSTEM (CCS). THE REPORTED CARBONIZATION WAS FOUND TO BE LINKED TO THE INITIAL FIBER, WHILE THE SECOND FIBER EXPERIENCED CARBON RESIDUE FROM THE FIRST FIBER RESULTING IN THE PREVENTION OF LASER ENERGY BEING TRANSFERRED INTO THE TISSUE. THE SECOND LDF WAS FOUND TO HAVE A SIMILAR CARBONIZATION EFFECT FROM THE LASER ENERGY. THE HARDWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS UNRELATED TO A SOFTWARE ISSUE. THE SOFTWARE FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A MEDTRONIC REPRESENTATIVE REPORTED THAT THE ISSUE OCCURRED DURING A HIPPOCAMPUS ABLATION. IT WAS NOTED THAT THE SURGEON DID NOT NOTICE THE COLOR CHANGE OF THE CATHETER. THE TEMPERATURE WAS INCREASED IN THE CATHETER TO 60% AND A BLUE STREAM WAS NOTICED GOING UP THE LASER. THE SURGEON THEN RAISED THE PERCENTAGE TO 90% AND STOPPED TO SEE IF THERE WAS DAMAGE. THE FLOW OF SALINE WAS REPORTED TO BE OPTIMAL. IT WAS NOTICED THAT THE LASER DIFFUSING FIBER (LDF) WAS REPLACED AND A TEST PULSE SHOWED EXPECTED HEATING. IT WAS THEN REPORTED THAT AN ABLATION WAS PERFORMED AND THE CATHETER WAS FOUND TO BE CHARRED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A LASER INDUCED THERMAL THERAPY (LITT), TWO LASER FIBERS IN THE PROCEDURE WERE CHARRED. THE REPORTED ISSUE OCCURRED WHEN PERFORMED AN ABLATION WAS PERFORMED AT 30% WITHOUT ANY SIGN OF HEAT BEING GENERATED. IT WAS REPORTED THAT A DWI AND FLAIR WERE PERFORMED WITHOUT INDICATION OF AN ABLATION BEING PERFORMED. THE REPRESENTATIVE THEN NOTED THAT THE FIRST FIBER WAS CHARRED. A SECOND FIBER WAS INSTALLED ONTO THE ABLATION SYSTEM, AND FOLLOWING A FEW ABLATIONS THE CATHETER WAS CHARRED. FUNCTIONALITY OF THE COOLING CATHETER SYSTEM (CCS) WAS REPORTED TO BE OPTIMAL. IT WAS REPORTED THAT THE ABLATION WAS INSUFFICIENT AND THAT THE SITE DID NOT COMPLETE THE PROCEDURE IN ITS ENTIRETY. THERE WAS A REPORTED DELAY TO THE PROCEDURE OF LESS THAN 1 HOUR DUE TO THIS ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649993 SYSTEM 9735542 15W VISUALASE POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE) 00643169655935

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention