BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENACURE NEVERTOUCH

    MDR report key: 2973508 · Received February 15, 2013

    Report

    Report Number
    1319211-2013-00015
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    PMA / PMN Number
    K031233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG # 11403002. IT WAS REPORTED THAT THE DISPOSABLE DEVICE WAS DISCARDED BY THE USER AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR ANY DEVIATIONS. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. AS REPORTED, THE PATIENT HAS NOT SUFFERED ANY PERMANENT HARM OR INJURY DUE TO THIS EVENT. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION AND ANY FOLLOW UP INFORMATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED (B)(6) 2013, A MALE PATIENT OF UNKNOWN AGE PRESENTED FOR AN ENDOVENOUS LASER TREATMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING 65M TRE-SHEATH WITH A 45CM FIBER IN CONJUNCTION WITH EACH OTHER. THERE WERE NO REPORTED PROCEDURAL COMPLICATIONS OR DEVICE FAILURES AT THAT TIME. TWO DAYS POST PROCEDURE, DURING A ROUTINE FOLLOW UP, THE RADIOLOGIST NOTED A PIECE OF THE 65CM SHEATH REMAINING INSIDE THE PATIENT. IT WAS REPORTED THAT WHEN THE LASER HAD FIRED, THE 45CM FIBER HAD BURNT OFF APPROXIMATELY 10CM OF THE 65CM TRE-SHEATH. THIS FRACTURED PIECE REMAINED INSIDE THE PATIENT. THIS HAD NOT BEEN NOTICED BY THE TREATING PHYSICIAN AT THE TIME OF THE PROCEDURE. THE PATIENT HAD NOT COMPLAINED OF ANY PAIN PRIOR TO THE DISCOVERY OF THE FRACTURED PIECE DUE TO THE EVENT. THE TREATING PHYSICIAN WAS IMMEDIATELY CONSULTED AND THE PATIENT WAS SCHEDULED FOR A RETRIEVAL OF THE FRACTURED PIECE ON THAT SAME DAY. THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION AND RELEASED THE NEXT DAY WITH NO REPORTED COMPLICATIONS. IT WAS REPORTED THE PATIENT SUFFERED NO PERMANENT HARM OR INJURY TO THE PATIENT DUE TO THE EVENT. THE REPORTED DEVICES ARE NOT AVAILABLE FOR EVALUATION AS THEY WERE DISPOSED OF BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69487 VENACURE NEVERTOUCH ENDOVENOUS LASER TREATMENT FIBER GEX ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention