BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 3001325 · Received March 6, 2013

    Report

    Report Number
    1319211-2013-00024
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FOR EVALUATION WAS ONE VENACURE EVLT NEVERTOUCH-FRS PROCEDURE KIT 45 CM FIBER. VISUAL EXAMINATION NOTED NO ABNORMALITIES. HOWEVER, FUNCTIONAL TESTING AND MEASUREMENT SPECIFICATIONS PERFORMED NOTED THE SHEATH LOK FITTING WAS FOUND TO BE APPROXIMATELY 70 CM ALONG THE FIBER WHICH IS NOT CONSISTENT WITH A 45 CM FIBER. FURTHER EXAMINATION NOTED THAT SHEATH LOK FITTING MOVED EASILY ALONG THE LENGTH OF THE FIBER. THE APPEARANCE OF ADEQUATE ADHESIVE SURROUNDING THE SHEATH LOK WAS NOTED. THE LOCATION OF THE ADHESIVE IS CONSISTENT WITH PROPER MANUFACTURING. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION IS CONFIRMED. THE MOST LIKELY ROOT CAUSE FOR THE REPORTED COMPLAINT DESCRIPTION IS HANDLING DAMAGE AFTER THE DEVICE LEFT THE MANUFACTURING FACILITY. EXCESSIVE FORCE DURING USE IN A CLINICAL SETTING MAY CAUSE THE SHEATH LOK FITTING TO DETACH FROM THE FIBER. DURING THE MANUFACTURING PROCESS, THE SHEATH LOK FITTING RECEIVED A 3LB. TENSILE TEST. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. THE INSTRUCTIONS FOR USE WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER STATES, "CONFIRM LOCATION OF THE FIBER USING ULTRASOUND GUIDANCE." A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED ON (B)(6) 2013, A FEMALE PATIENT OF UNKNOWN AGE PRESENTED FOR AN ENDOVENOUS LASER TREATMENT. THE FIRST ABLATION PERFORMED DURING THE PROCEDURE REPORTED NO COMPLICATIONS. WHEN THE TREATING PHYSICIAN ADVANCED THE FIBER DURING THE SECOND ABLATION, THE PATIENT NOTIFIED THE TREATING PHYSICIAN OF PAIN IN THE LOCATION OF THE ADVANCING FIBER. THE PHYSICIAN NOTED HE STILL HAD APPROXIMATELY 10CM OF FIBER TO ADVANCE, SO HE CONTINUED TO ADVANCE THE FIBER. THE PATIENT AGAIN NOTIFIED THE TREATING PHYSICIAN OF PAIN IN THE LOCATION OF THE ADVANCING FIBER WHEN HE ADVANCED THE FIBER FOR THE SECOND TIME. THE TREATING PHYSICIAN PULLED BACK ON THE FIBER AND NOTICED THE CONNECTOR LOCK HAD DISLODGED FROM THE FIBER, ALLOWING THE FIBER TO ADVANCE FURTHER THAN EXPECTED. AFTER SUCCESSFULLY COMPLETING THE PROCEDURE, AN ULTRASOUND WAS PERFORMED ON THE PATIENT; THERE WAS NOTHING OF SIGNIFICANCE NOTED ON THE SCAN. IT WAS REPORTED THE PATIENT WAS SENT HOME THE FOLLOWING DAY WITH NO REPORTED COMPLICATIONS, AND NO PERMANENT HARM OR INJURY DUE TO THE EVENT. THE REPORTED FAILED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95889 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS 585618

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention