BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 002-1100 15W THERMAL THERAPY

    MDR report key: 5062168 · Received September 8, 2015

    Report

    Report Number
    1723170-2015-01070
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 11, 2015
    Report Date
    November 24, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER ENGINEERING EVALUATION FOUND THAT TWO COMPLETE VISUALASE COOLED LASER APPLICATOR SYSTEM (VCLAS) T15¿S WERE RETURNED FOR EVALUATION. BOTH COOLING CATHETER SYSTEMS (CCS) SHOWED CHARRING AND MELTING. ONE LASER DIFFUSING FIBER (LDF) LOOKED FINE, AND THE SECOND LDF LOOKED LIKE IT BURNED ITSELF UP AT THE QUARTZ FIBER TO SILICON TITANIUM DIOXIDE INTERFACE. IT APPEARS TWO DIFFERENT FAILURES WERE INVOLVED HERE: 1) BOTH CCS EXPERIENCE MELTING. 2) ONE OF THE LDF¿S BURNED UP WHICH MAY OR MAY NOT HAVE CAUSED AND/OR CONTRIBUTED TO THE CCS CHARRING AND MELTING.

    Additional Manufacturer Narrative · 1

    MEDTRONIC ENGINEERS PERFORMED MICROSCOPIC EXAMINATION OF A CCS(COOLING CATHETER SYSTEM)-600 WHICH WAS RECEIVED WITH A LDF (LASER DIFFUSING FIBER)-T15 WHICH HAD EVIDENCE OF HAVING BURNED UP. THE BURNED AREA OF THE LDF WAS MEASURED TO BE ~15 MM FROM THE DISTAL TIP OF THE LDF. BURNING RESULTED IN CHARRING OF THE TEFLON SLEEVE AND/OR THE SILICONE TITANIUM DIOXIDE INSIDE THE SLEEVE NEAR THE AREA OF THE QUARTZ-FIBER CORE. THIS IS BELIEVED TO BE THE VCLAS (VISUALASE COOLED LASER APPLICATOR SYSTEM) USED IN THE PROCEDURE FOR TARGET 1A WHERE THE IMAGING DID NOT LOOK RIGHT. A BLISTER WAS FOUND ON THE EXTERNAL SURFACE OF THE CCS AS WAS LOCATED ~2 CM AWAY FROM THE DISTAL TIP OF THE CCS. THE SAME BLISTER SHOWN AT HIGHER MAGNIFICATION SHOWS A HOLE IN THE OUTERWALL OF THE CCS IS CLEARLY VISIBLE. A SCALPEL WAS USED TO BISECT THE CCS AT THE POINT OF THE BLISTER. INSPECTION OF THE CROSS SECTIONS OF THE BLISTERED AREA SHOW THAT THE INNER LUMEN (ALSO CALLED THE CCS-I) SHOWS SIGNS OF CHAR AND MELTING INTERNALLY. THE CCS-I APPEARS TO HAVE MELTED INTO THE CCS-O (THE OUTER WALL OF THE CCS). THE CCSI COULD NOT BE PULLED AWAY FROM THE CCSO INDICATING THE INNER AND OUTER LUMEN HAD BONDED TOGETHER. THE DISTAL TIP OF THE CCS APPEARS UNDAMAGED. A SECOND AREA OF MELTING DAMAGE ON THE SURFACE OF THE CCSO WAS OBSERVED ON THE CCS. THIS SECOND AREA OF DAMAGE WAS LOCATED ~3.6 CM FROM THE DISTAL TIP OF THE CCS. THE DAMAGED AREA WAS A SMALL HOLE MELTED FROM THE OUTER SURFACE OF THE CCSO. THIS DAMAGED AREA APPEARS TO HAVE BEEN ISOLATED TO THE SURFACE OF THE CCSO AND DID NOT INVOLVE THE INNER LUMEN (CCSI). THIS DAMAGED AREA WAS LOCATED APPROXIMATELY 1.5 CM AWAY FROM THE BLISTERED DAMAGE AREA. THE SECOND CCS-600 WHICH WAS RECEIVED WITH A LDF-T15 WHICH APPEARED FULLY INTACT; FREE FROM ANY SIGNS OF CHAR, MELTING OR ANY OTHER THERMAL DAMAGE. THE CCS HAD SIGNIFICANT CHAR ON SEVERAL SPOTS ALONG THE EXTERIOR OF THE OUTER SURFACE TO INCLUDE THE TIP AND FURTHER UP THE BODY OF THE CCS. THREE IMAGES OF THE CCS WERE PATCHED TOGETHER TO CREATE A STITCHED IMAGE OF THE APPEARANCE OF THE DAMAGED AREAS. THE INNER LUMEN WAS PULLED OUT AND PLACED SIDE-BY-SIDE TO THE OUTER BODY TO INSPECT FOR ANY CORRELATING DAMAGED AREAS ON THE CCSI TO THE CCSO. THE INNER LUMEN APPEARED FREE OF CHAR AND MELTING IN NEARLY ALL AREAS. THERE WAS SOME SMALL AMOUNT OF MELTING IN THE CCSI AT THE BEND. IT IS NOT CLEAR HOW THIS DAMAGE OCCURRED. THE INTERIOR WALL OF THE CCSO APPEARED SMOOTH AND UNDAMAGED IN MOST AREAS, BUT DID SHOW SIGNS WHERE THE EXTERIOR WALL DAMAGE HAD MELTED INTO THE INTERIOR WHERE CHAR WAS OBSERVED ON THE SURFACE CONCLUSIONS: ONE OF THE LDF UNITS BURNED UP AND THE OTHER DID NOT. BOTH CCS UNITS MELTED. ONE CCS HAD DAMAGE IN MULTIPLE AREAS ALONG BODY OF CATHETER TO INCLUDE THE BLISTER AND A SECOND AREA WITH DAMAGE ON THE EXTERIOR SURFACE OF THE CCSO. THESE TWO DAMAGED AREAS SUGGEST THE CCS MELTED BOTH VIA EVENT A AND EVENT B. THE OTHER CCS MELTED VIA EVENT A ONLY. EVENT A: HOLE MELTS THROUGH SURFACE OF CCSO LIKELY DUE TO EXCESSIVE LASER POWER AND EXPOSURE TIME LEADING TO HIGH TEMPERATURE CONDITIONS EXPERIENCED AT THE SURFACE OF THE CCSO. EVENT B: HOLE MELTS THROUGH THE INTERIOR OF THE CCS FROM THE INSIDE-OUT DUE TO THERMAL DEGRADATION OF THE LDF. THIS ISSUE WILL BE TRENDED AND MONITORED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    OPERATOR OF DEVICE IS A MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE, SPECIALLY TRAINED TO USE THE LASER INDUCED THERMAL THERAPY SYSTEM. (B)(6) 2015 A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED: --TARGET 1A TEST DOSE 30/97% 9W 20SECONDS. REAL DOSE 90/97% 27W 30 SECONDS IMAGING DID NOT LOOK RIGHT. HEATING AND DAMAGE UP THE FIBER TRACT WITHIN ANATOMY ON IMAGING. LASER FIBER BURNT AND BROKE WHEN WE CAME ON REAL ABLATION DOSE. NEW FIBER. NEW CCS; TEST DOSE 9W 15 SECONDS. REAL DOSE 27W 4MIN FINE AFTER FIRST ROUND. --TARGET 1B SAME FIBER AND CCS TEST DOSE 15SEC 30/90% REAL DOSE 3MINS 90/97% 27W PULL BACK REAL DOSE 4MINS 90/97% 27W - RETURN REQUESTED. THE DAMAGED INSTRUMENTS ARE DISPOSABLES AND DO NOT REQUIRE REPLACEMENT. MEDTRONIC INVESTIGATION OF RETURNED SUSPECT .4MM CORE FIBER 10MM TIP FINDS THAT BOTH FIBERS ARE BENT AND BURNT. PHYSICAL DAMAGE - BURNT FIBER. - NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED CHARRED CATHETERS AND BURNED LASER DIFFUSING FIBER (LDF) WHILE IN A KIDNEY ABLATION PROCEDURE. THE DAMAGED INSTRUMENTS ARE DISPOSABLES AND DO NOT REQUIRE REPLACEMENT. NO FURTHER DETAILS WERE PROVIDED. 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
    591304 SYSTEM 002-1100 15W THERMAL THERAPY POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC. (LOUISVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR