BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV600R

    MDR report key: 3763393 · Received April 7, 2014

    Report

    Report Number
    2951571-2014-00002
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    January 9, 2014
    Report Date
    April 4, 2014
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K051434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN EXPERIENCED FIBER BREAKAGE WHILE PERFORMING LASER TREATMENT FOR VENUOUS INSUFFICIENCY INVOLVING THE SMALL SAPHENOUS VEIN (SSV). DURING PULL BACK OF THE FIBER OPTIC, THE FIBER FRACTURED AND BROKE INSIDE THE PATIENT. AN INCISION WAS MADE AND THE BROKEN PIECE WAS SUCCESSFULLY RETRIEVED. THE PATIENT'S LEG WAS SCANNED VIA ULTRASOUND FOR ANY REMAINING PIECES; NONE WERE FOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT RECEIVED FOLLOW-UP EVALUATIONS AND WOUND CARE FOR THE INCISION. FURTHER VEIN TREATMENTS WERE ALSO PERFORMED. PHYSICIAN DID NOT REPORT THE INCIDENT TO NEW STAR LASERS AT THE TIME. ABOUT TWO MONTHS LATER, THE PATIENT WENT TO THE EMERGENCY ROOM FOR CHEST PAIN. THE HOSPITAL CONTACTED NEW STAR LASERS, BECAUSE IT WAS DETERMINED THERE WAS A FOREIGN BODY IN THE RIGHT VENTRICLE, AND PHYSICIANS AT THAT HOSPITAL SUSPECT THAT A BROKEN PIECE OF FIBER TRAVELED UP INTO THE HEART. THIS IS TO DATE UNCONFIRMED AND THERE IS NO FURTHER INFO. THE PATIENT WAS NON-SYMPTOMATIC AND WAS SENT HOME TO RETURN FOR AN MRI AND A TRANSTHORACIC ECHO TO BE PERFORMED A MONTH LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205716 MODEL EV600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. EV600R

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention