BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 1243144 · Received November 21, 2008

    Report

    Report Number
    1319211-2008-00055
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL INSPECTION OF THE SUPPLIED PHOTOS. THE PHOTOS SHOW THE SHEATH BURNT IN TWO PIECES AND THE DISTAL TIP OF THE FIBER IS NOT IN THE PHOTOS. THE EXACT CAUSE OF THE COMPLAINT IS UNK. POSSIBLE CAUSES AREA EITHER THE FIBER CRACKED DURING HANDLING CAUSING THE HEAT TO COME OUT AT THE BREAK INSTEAD OF THE TIP OR THAT THE FIBER WAS NOT LOCKED IN TO THE SHEATH LOK-FITTING CAUSING IT TO NOT BE FULLY THROUGH THE SHEATH BEFORE IT WAS FIRED. DURING A REVIEW OF THE MANUFACTURING RECORDS, IT WAS OBSERVED THAT THE MANUFACTURED LOTS MEET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. NO OTHER COMPLAINTS OF THIS TYPE HAVE BEEN REPORTED FOR THE COMPLAINT LOT NUMBER. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING TO HELP PREVENT THIS TYPE OF COMPLAINT: VERIFY LOCATION OF THE NEVERTOUCH LASER FIBER AND SHEATH END USING ULTRASOUND. REMOVE FIBER STOP ASSEMBLY. PULL THE SHEATH BACK AND LOCK IT TO THE SHEATH-LOK FITTING. CONFIRM LOCATION OF THE FIBER USING ULTRASOUND GUIDANCE. CHECK POSITION OF FIBER END AND SLIDING SHEATH GAUGE; ADJUST POSITION IF NECESSARY. INSERT THE NEVERTOUCH LASER FIBER INTO THE SHEATH SO THE DISTAL END OF THE FIBER AND DISTAL END OF THE SHEATH ARE AT THE SAME POINT. THIS IS ACHIEVED BY ADVANCING THE FIBER THROUGH THE SHEATH UNTIL THE FIBER STOP ASSEMBLY COMES IN CONTACT WITH THE PROXIMAL END OF THE SHEATH HUB. PRECAUTION: PRIOR TO AND DURING USE, AVOID DAMAGING THE FIBER BY STRIKING, STRESSING OR EXCESSIVE BENDING OF THE FIBER. DO NOT COIL THE FIBER TIGHTER THAN A DIAMETER OF 20CM. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. NO FURTHER ACTION AT THIS TIME. FREQUENCY HAS INCREASED BUT THE SEVERITY OF THIS EVENT IS NOT GREATER THAN USUAL.

    Description of Event or Problem · 1

    A PROBLEM WITH A BURNT SHEATH DURING A LASER VEIN ABLATION. TRE SHEATH WAS BURNT APPROX 20CM BACK FROM THE TIP. TRE SHEATH WAS BURNT IN HALF W/ A PORTION OF THE SHEATH LEFT BEHIND IN THE PT. REMAINING 20 CM OF TRE SHEATH WERE REMOVED DURING A CUT DOWN/ STRIPPING PROCEDURE. I COULD NOT FIND THE REMAINING 20CM OF THE LASER FIBER INCLUDING THE GOLD TIP. DR PATEL REMOVED THE REMAINING TRE SHEATH AND THE ENTIRE VEIN WHILE SHE WAS STRIPING THE VEIN - CONFIRMING FOR ME THAT THERE WAS NO CHANCE OF A FIBER BEING LEFT INSIDE THE PT SINCE THE SHEATH AND THE VEIN WERE ALL REMOVED. UPON MY INTERVIEW WITH PEDRO RAMOS (ULTRASOUND TECH) RECALLS HAVING DIFFICULTY LOCATING THE FIBER TIP DURING THE SECOND VEIN. HE DOES NOT RECALL SEEING OR NOT SEEING THE RED LIGHT UNDER THE SKIN. HE LEFT THE ROOM WITH HIS MACHINE ONCE THE STRIPPING PROCEDURE TO REMOVE THE TRE SHEATH BEGAN. NO ULTRASOUNDS WERE PERFORMED AFTER THAT. NOTE: THE 1ST VEIN WAS PERFORMED WITH COMPLETE SUCCESS, NO BURNT SHEATH, ULTRASOUND CONFIRMS CLOSURE AND COMMON FEMORAL PATENT. THE 2ND VEIN WAS THE PROBLEM WHICH CONFIRMS THE FIBER WAS COMPLETE AND USABLE FOR THE FIRST PART OF THE PROCEDURE. THE SAME KITS WERE USED FOR BOTH VEINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENACURE NEVERTOUCH ENDOVASCULAR LASER VENOUS SYSTEM GEX ANGIODYNAMICS, INC. 954071

    Patients

    Seq Age Sex Outcome Treatment
    1