BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 2051546 · Received February 24, 2011

    Report

    Report Number
    1319211-2011-00024
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 24, 2011
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE USED SHEATH AND FIBER. A VISUAL REVIEW OF THE FIBER NOTED NO DEFECTS. THE FIBER WAS MEASURED TO BE CONSISTENT WITH THE SPECIFICATIONS OF A 45 CM FIBER. A VISUAL REVIEW OF THE SHEATH NOTED THAT IT WAS BURNT AT APPROXIMATELY 17 CM MARK ON THE SHEATH. WHEN LAID OUT, SUCH THAT THE LUER OF THE FIBER MATED UP WITH THE LUER ON THE SHEATH, THE FIBER TIP REACHED BURN POINT ON THE SHEATH. THE COMPLAINT IS CONFIRMED. THE ROOT CAUSE FOR THE REPORTED COMPLAINT BASED ON FOLLOW UP INFORMATION PROVIDED BY THE SALES REP, IS THAT PHYSICIAN BEGAN THE PROCEDURE WITH A NEVERTOUCH 45 CM KIT. WHILE ATTEMPTING TO REMOVE THE 45 CM DILATOR FROM THE PATIENT, THE HEMOSTASIS ON THE 45 CM SHEATH BROKE. THE PHYSICIAN REPLACED THE 45 CM SHEATH WITH A SHEATH FROM A 65 CM NEVERTOUCH KIT. THE PHYSICIAN THEN PROCEEDED TO COMPLETE THE PROCEDURE WITH THE 45 CM FIBER FROM THE NEVERTOUCH 45 CM KIT. WHEN THE FIBER WAS ENGAGED, IT BURNED THROUGH THE SHEATH. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER, CONTAINS A STATEMENT: "CONFIRM LOCATION OF THE FIBER USING ULTRASOUND GUIDANCE. THE NEVERTOUCH FIBER END SHOULD BE 1-2 CM BELOW THE SAPHENO-FEMORAL JUNCTION WHEN TREATING THE GSV." THIS KIT RECEIVES TWO 100% INSPECTIONS DURING THE PACKAGING PROCESS TO ENSURE THE CORRECT COMPONENTS ARE INCLUDED IN THE KIT. DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THE REPORTED LOT IT WAS OBSERVED THAT THE MANUFACTURED LOTS MEET ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS PRODUCT FAMILY AND COMPLAINT TYPE. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2011 DURING AN ENDOVENOUS ABLATION, THE LASER FIBER WAS TOO SHORT FOR THE SHEATH CAUSING THE SHEATH TO BREAK OFF IN THE VEIN. THE PIECE OF THE SHEATH WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT. THERE WAS NO HARM TO THE PATIENT AND NO FURTHER MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS, INC. NA 532482

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention