BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 5155187 · Received October 15, 2015

    Report

    Report Number
    1723170-2015-01251
    Event Type
    Malfunction
    Date Received
    October 15, 2015
    Date of Event
    September 16, 2015
    Report Date
    November 19, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED: FINDINGS ARE AFTER A STUDY REVIEW FROM THE ABLATION SESSION LOG FILES: SOME SESSIONS WERE CLOSED BEFORE TISSUE TEMPERATURE RETURNED TO BASELINE; THEREFORE, THERE IS A POSSIBILITY THAT THE SUBSEQUENT PHASE REFERENCE SETTING ASSUMED A LOWER THAN ACTUAL STARTING BASE TEMPERATURE, ESPECIALLY AFTER MULTIPLE, LONG, HIGH LASER POWER ABLATIONS. BLACK REGIONS SURROUNDING LASER FIBER TIP, PRESENT BEFORE THE FIRST ABLATION, MAY HAVE PREVENTED NORMAL HEAT DISSIPATION FROM THE FIBER TIP. WARM WATER FLOW-LIKE ALONG THE FIBER PATH NOTICED BY THE BEGINNING OF FIRST ABLATION SUGGEST EITHER A LEAKAGE FROM THE CATHETER OR RELATIVELY POOR WATER CIRCULATION THAT WOULD NOT CARRY OUT EXCHANGING COOLING WATER FAST ENOUGH FROM AN EXTREMELY HOT CATHETER. VARIOUS LONG CONSECUTIVE ABLATIONS AT HIGH LASER POWER COMBINED WITH DEFICIENT CATHETER COOLING WATER FLOW CONTRIBUTE TO THE LIKELIHOOD OF THE CATHETER TO BECOME MELTED AND THE LASER FIBER TO THEN BECOME CHARRED. NO INDICATIONS OF VISUALASE SOFTWARE MALFUNCTIONING WERE FOUND. VISUALASE SOFTWARE FUNCTIONING AS DESIGNED. ANALYSIS OF THE RETURNED SUSPECT COOLING CATHETER SYSTEM (CCS) AS FOLLOWS: FAILURE MODE: PHYSICAL DAMAGE. ABLE TO DUPLICATE THE ISSUE: YES. FINDING & CONCLUSIONS: CCS-400-11, LOT NUMBER 142747, LDF-400-12-T10, LOT NUMBER 142648 . THE LDF (LASER DIFFUSING FIBER) IS BENT AND BURNT ABOUT 3/8 OF AN INCH FROM THE TIP. THE CCS IS BURNT ABOUT HALF AN INCH FROM THE TIP ON BOTH SIDES OF THE CANNULA. BENT, CRACKED, MELTED. VISUAL INSPECTION OF THE CHARRED T10 LDF FOUND THAT THE LDF APPEARS TO HAVE BURNT AT THE QUARTZ FIBER TO SILICON TITANIUM DIOXIDE INTERFACE. THIS ISSUE WILL BE TRENDED AND MONITORED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    MEDTRONIC INVESTIGATION OF RETURNED SUSPECT 4MM CORE FIBER 10MM TIP FINDS THAT LASER DIFFUSING FIBER (LDF) IS BENT AND BURNT ABOUT 3/8 OF AN INCH FROM THE TIP. THE COOLING CATHETER SYSTEM (CCS) IS BURNT ABOUT HALF AN INCH FROM THE TIP ON BOTH SIDES OF THE CANNULA. PHYSICAL DAMAGE - BENT, CRACKED, MELTED. ENGINEERING INVESTIGATION NOTES: THE LDF APPEARS TO HAVE BURNED ITSELF UP AT THE QUARTZ FIBER TO SILICON TITANIUM DIOXIDE INTERFACE. ON (B)(6) 2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE ABLATION ENDED WHEN THE REPORTED ISSUE OCCURRED. IN THE FINAL SESSION, THEY WE WERE NOT GETTING HEAT; ON THE MAP THEY WERE AT A TEST DOSE SET AT 30% OF 15 W. A PIN-HOLE LEAK IN THE COOLING CATHETER SYSTEM (CCS) WAS NOTED, BUT THAT MAY HAVE OCCURRED POST-OP WHEN REMOVING THE BOLT. THE PUMP AND COOLING SYSTEM WERE NORMAL. THE UTILIZATION OF THE SALINE APPEARED NORMAL, TOO. THEY WERE CONSIDERING AN ADDITIONAL ABLATION; HOWEVER, THE SURGEON RAN A DWI AND DECIDED THE SESSION WAS COMPLETE. NO FURTHER TREATMENT WAS PERFORMED. PATIENT WAS BEING TREATED FOR A TEMPORAL LOBE TUMOR. NO APPARENT COMPLICATIONS HAVE BEEN REPORTED. IN THE SURGERY WHEN THE CATHETER WAS PULLED OUT, THERE WAS A HOLE IN IT. THE SURGEON DID NOT THINK THIS HAD ANY IMPACT ON THE PROCEDURE. ON (B)(6) 2015 THE SURGEON STATED THE PATIENT'S POST-OP RECOVERY HAS BEEN NORMAL AND PATIENT WAS DOING WELL. ON (B)(6)2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED ONLY ONE COOLING CATHETER WAS USED FOR ALL ABLATIONS. ON (B)(6) 2015 SOFTWARE ANALYSIS WAS UNABLE TO DETERMINE PROBABLE CAUSE WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A LASER INDUCED THERMAL THERAPY PROCEDURE, THE SITE HAD A CHARRED LASER FIBER TIP. THIS PROCEDURE WAS STARTED WITH ONE LESION BIOPSY WHICH WAS COMPLETED SUCCESSFULLY. THE MEDTRONIC REPRESENTATIVE STATED THERE MAY HAVE BEEN A LITTLE BIT OF BLOOD FROM THE BIOPSY WHEN THE LASER ABLATION BEGAN. AFTER THE THIRD ABLATION, THEY DID NOT SEE HEATING ON THE SOFTWARE, SO PULLED OUT THE LASER FIBER. THE TIP HAD BEEN CHARRED AND THE DIFFUSION PATTERN WAS BRIGHTER AT THE DISTAL TIP FOR THE AIMING BEAM. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE THERMAL THERAPY SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682344 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR