BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    400 MICRON FIBER PROCEDURE KIT

    MDR report key: 21917300 · Received April 28, 2025

    Report

    Report Number
    1319211-2025-00023
    Event Type
    Malfunction
    Date Received
    April 28, 2025
    Date of Event
    April 7, 2025
    Report Date
    August 18, 2025
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    UDI-DI
    H787EVLTPVAK5
    PMA / PMN Number
    K041957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND AN INVESTIGATION INTO THE ROOT CAUSE FOR EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    RECEIVED ONE (1) PVAK FIBER FOR EVALUATION. VISUAL/MICROSCOPIC EXAM: AS RECEIVED, THE PVAK WAS RETURNED IN ONE PIECE WITH TIP STILL ATTACHED (APPROXIMATELY 16CM FROM BLACK MARKER BAND TO TIP). THE FIBER WAS CONNECTED TO THE TAGWRITE READER AND CONFIRMED FIBER WAS FIRED (NUMBER OF USES = 1) AND LOT NUMBER IS 5841258. THE RETURNED PVAK FIBER WAS INTACT WITH NO FRACTURES TO THE FIBER. IT WAS CONFIRMED THAT THE DISTAL TIP OF THE FIBER IS BURNT/MELTED DUE TO THE END USER FIRING THE LASER FIBER OUTSIDE OF THE BODY (AT THE FLOOR). THIS IS END USER ERROR AS FIBER IS NOT MEANT TO BE FIRED OUTSIDE OF THE PATIENT'S BODY. WHEN CHECKING THE AIMING BEAM OF THE FIBER THE LASER GENERATOR IS TO BE IN AIMING BEAM MODE WHICH PREVENTS THE LASER GENERATOR FROM FIRING IN THE READY STATE. THE CUSTOMER'S REPORTED COMPLAINT OF THE FIBER TIP BECAME BURNT/MELTED WAS CONFIRMED BASED ON EVALUATION OF THE RETURNED COMPLAINT SAMPLE. THE FIBER WAS INTACT WITH NO FRACTURES BUT DISTAL TIP HAD HEAT RELATED DAMAGE. THE ROOT CAUSE OF THIS HEAT RELATED DAMAGE WAS END USER FIRING THE LASER FIBER OUTSIDE OF THE BODY (AT THE FLOOR). THIS IS END USER ERROR AS FIBER IS NOT MEANT TO BE FIRED OUTSIDE OF THE PATIENT'S BODY. WHEN CHECKING THE AIMING BEAM OF THE FIBER THE LASER GENERATOR IS TO BE IN AIMING BEAM MODE WHICH PREVENTS THE LASER GENERATOR FROM FIRING IN THE READY STATE. A DHR REVIEW OF THE INDICATED PACKAGING/ASSEMBLY LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. DURING THE MANUFACTURING PROCESS, THE DISPOSABLE FIBER DEVICE RECEIVES A 100% INSPECTION AND AN AQL INSPECTION IN WHICH THE QUALITY OF THE FIBER STRIP IS INSPECTED. PRIOR TO PACKAGING, ALL COMPONENTS ARE INSPECTED FOR DAMAGE. HARDWARE UNIT REVIEW: THE SERIAL NUMBER OF THE HARDWARE UNIT USED DURING THIS EVENT WAS NOT REPORTED BY THE COMPLAINANT. A REVIEW OF THE HARDWARE CASE/SERVICE ORDER HISTORY RECORDS CANNOT BE PERFORMED. IN ADDITION, THIS CUSTOMER ACCOUNT DID NOT REQUEST A SERVICE ORDER (COMPLAINT) FOR THEIR HARDWARE UNIT AT THE TIME OF THIS PROBE EVENT. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU, 14601411-01) WHICH IS SUPPLIED TO THE END USER WITH THE EVLT FIBER CONTAINS THE FOLLOWING STATEMENTS: WARNING CONTENTS SUPPLIED STERILE USING AN ETHYLENE OXIDE (EO) PROCESS. DO NOT USE IF STERILE BARRIER IS DAMAGED. IF DAMAGE IS FOUND, CALL YOUR SALES REPRESENTATIVE. INSPECT PRIOR TO USE TO VERIFY THAT NO DAMAGE HAS OCCURRED DURING SHIPPING. INTENDED USE THE VENACURE EVLT 400 [?]M PERFORATOR AND ACCESSORY VEIN ABLATION KIT IS INTENDED FOR USE IN THE TREATMENT OF SUPERFICIAL VEIN REFLUX OF THE GREATER SAPHENOUS VEIN ASSOCIATED WITH VARICOSITIES. THE VENACURE EVLT 400 [?]M PERFORATOR AND ACCESSORY VEIN ABLATION KIT IS INDICATED FOR TREATMENT OF INCOMPETENCE AND REFLUX OF SUPERFICIAL VEINS IN THE LOWER EXTREMITY, AND FOR TREATMENT OF INCOMPETENT (I.E. REFLUXING) PERFORATOR VEINS (IPVS). EQUIPMENT HANDLING REQUIREMENTS VENACURE EVLT 400 [?]M PERFORATOR AND ACCESSORY VEIN ABLATION KIT: USING STERILE TECHNIQUE OPEN THE PACK, PLACE ALL CONTENTS INTO STERILE FIELD AND INSPECT FOR DAMAGE. DO NOT USE IF ANY COMPONENT IS DAMAGED. IF DAMAGE IS PRESENT, CONTACT CUSTOMER SERVICE OR YOUR LOCAL REPRESENTATIVE. LASER GENERATOR: THE USER MANUAL (MAN/31/0075), WHICH IS SUPPLIED TO THE END USER WITH THIS UNIT, STATES: WARNING: BEFORE USING A FIBER, CHECK IT CAREFULLY FOR ANY SIGNS OF DAMAGE DURING STORAGE OR TRANSIT. PROTECTIVE CAPS SHOULD BE IN PLACE OVER SMA CONNECTORS. DO NOT USE IF THERE IS ANY SIGN OF DAMAGE. AIMING BEAM: THE AIMING BEAM CAN OPERATE IN THREE MODES, WHICH CAN BE SELECTED BY CHOOSING MODE WITH SCROLL KNOB: - OFF - CONTINUOUS - FOLLOW LASER IMPORTANT POINT TO BE NOTED: TO OBSERVE THE DIFFERENT MODES OF THE AIMING BEAM, PLACE THE VENACURE 1470 LASER INTO READY MODE BY PRESSING THE STANDBY/READY BUTTON. THE AIMING BEAM WILL BE ACTIVATED IF CONTINUOUS OR FOLLOW LASER ARE SELECTED. FOR SAFETY, IT IS NOT POSSIBLE TO FIRE THE LASER IN READY STATE AT THIS MENU. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    A TERRITORY MANAGER REPORTED AN END USER EXPERIENCED AN ISSUE WHEN USING A PVAK -- 400 MICRON FIBER PROCEDURE KIT. AFTER THE LASER FIBER WAS HOOKED UP TO THE MACHINE, PRIOR TO USING IT ON THE PATIENT, THE DOCTOR ACTIVATED THE LASER ON THE FLOOR OUTSIDE THE PATIENT TO MAKE SURE THAT IT WAS ON AND VISIBLE SMOKE CAME OUT OF THE TIP OF THE LASER. WHEN INSPECTING THE FIBER, IT WAS NOTED THE FIBER LOOKED LIKE IT WAS MELTING. THE PROCEDURE WAS COMPLETED WITH A NEW OF THE SAME DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237380 400 MICRON FIBER PROCEDURE KIT POWERED LASER SURGICAL INSTRUMENT GEX ANGIODYNAMICS 5841258 H787EVLTPVAK5

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown