BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEVER TOUCH VENACURE

    MDR report key: 1243142 · Received November 21, 2008

    Report

    Report Number
    1319211-2008-00049
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 10, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE COMPLAINT INVESTIGATION HAS BEEN CONFIRMED DURING THE VISUAL EVALUATION OF THE RETURNED SAMPLE. THE SHEATH WAS RETURNED IN TWO PIECES THAT HAD BURNT APART BETWEEN THE 3-4 CM MARKING. THE FIBER WAS RETUNED IN ONE PIECE. THE FIBER WAS INTERFACED WITH THE SHEATH, 6CM OF THE FIBER STUCK OUT OF THE DISTAL TIP OF THE SHEATH. THE FIBER STOP IS SECURED ON THE FIBER AT 51CM. WHEN THE FIBER WAS OBSERVED THROUGH A MICROSCOPE, A SMALL CRACK 4 CM FROM THE DISTAL TIP OF THE FIBER WAS OBSERVED. THE DISTAL TIP OF THE FIBER GIVES THE APPEARANCE OF BEING FIRED. THE EXACT CAUSE OF THE COMPLAINT IS UNK. POSSIBLE CAUSES ARE EITHER THE FIBER CRACKED DURING HANDLING CAUSING THE HEAT TO COME OUT AT THE BREAK INSTEAD OF THE TIP AND THAT THE FIBER WAS NOT LOCKED IN TO THE SHEATH LOK FITTING CAUSING IT TO NOT BE FULLY THROUGH THE SHEATH BEFORE IT 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 OF GREATER THAN USUAL.

    Description of Event or Problem · 1

    EARLIER THIS WEEK, WHILE PERFORMING A ROUTINE ABLATION OF A SHORT SAPHENOUS VEIN, THE LASER ABLATION WAS COMPLICATED BY FRACTURE AND RETENTION OF THE DISTAL 3.5CM OR SO OF THE 45 CM LENGTH BRAIDED ENDOVENOUS LASER SHEATH SUPPLIED BY ANGIODYNAMICS. WHEN THE INTACT REMAINING PARTS OF THE SHEATH AND THE INTACT-APPEARING ENDOVENOUS LASER FIBER WERE REMOVED, THE DISTAL ASPECT OF THE SHEATH WAS CLEARLY BURNED AND AFTER IT WEAKENED SUFFICIENTLY FROM THE HEAT GENERATED BY THE LASER FIBER, IT OBVIOUSLY PULLED APART, WITH SOME OF THE INTERNAL BRAIDS REINFORCING THE WALL OF THE SHEATH CLEARLY VISIBLE AND PARTIALLY CHARRED. THE PT HAS EXPERIENCED NO ILL EFFECTS FROM THIS COMPLICATION, OTHER THAN HAVING TO UNDERGO A SECOND PROCEDURE YESTERDAY, DURING WHICH I SUCCESSFULLY RETRIEVED THE "LOOSE" ENDOVENOUS SHEATH FRAGMENT PERCUTANEOUSLY WITH A SNARE. IT APPEARS LIKELY THAT A TINY CRACK OR DEFECT IN THE LASER FIBER MAY HAVE ALLOWED SOME OF THE ENERGY TO EXIT THE FIBER PROXIMAL TO THE GOLD TIP (WHICH REMAINED INTACT), THUS CAUSING THE SHEATH TO HEAT UP, MELT AND ULTIMATELY FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEVER TOUCH VENACURE LASER VEIN TREATMENT GEX ANGIODYNAMICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention