BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTOUCH

    MDR report key: 6764687 · Received July 26, 2017

    Report

    Report Number
    6764687
    Event Type
    Injury
    Date Received
    July 26, 2017
    Date of Event
    July 11, 2016
    Report Date
    July 7, 2017
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT AN ENDOVENOUS LASER ABLATION OF THE RIGHT GREATER SAPHENOUS VEIN ON (B)(6)2016. DURING THE PROCEDURE, THE LASER FIBER WAS CONFIRMED TO MOVE OUT OF THE RIGHT LEG BY BOTH THE BEAM EMITTED FROM THE LASER TIP AND ULTRASOUND OBSERVATION OF THE CONTINUOUS FIBER MOVEMENT FROM PROXIMAL TO DISTAL LEG. FOLLOWING EXTRACTION, THE FIBER WAS INTACT. THE PROCEDURE WAS UNEVENTFUL AND PATIENT TOLERATED WELL. IN (B)(6) OF 2016, THE PATIENT REPORTED TO THE ER WITH COMPLAINT OF PAIN IN THE RIGHT UPPER LEG. DIAGNOSTIC STUDIES SUSPECTED UNINTENTIONAL RETAINED FOREIGN OBJECT. ON (B)(6)2017, VASCULAR SURGERY REMOVED A 32 CM FOREIGN BODY FROM THE SAPHENOUS VEIN BELIEVED TO HAVE BEEN LEFT BEHIND FOLLOWING THE ENDOVENOUS LASER ABLATION IN (B)(6) OF 2016. THE LASER FIBER USED IN THE PROCEDURE WAS A STERILE SINGLE USE 600 MICRON FIBER. THE MANUFACTURER REPORTED THAT IT WAS THE FIRST TIME THEY HAD USED THAT PARTICULAR COMPANY TO STERILIZE THEIR FIBERS. THE EXTRACTED UNINTENTIONALLY RETAINED FOREIGN OBJECT WAS SENT TO PATHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526405 COOLTOUCH 600 MICRON FIBER - STERILE SINGLE USE GEX NEW STAR LASERS, INC. EV 600 S LP901

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention