BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLTOUCH

    MDR report key: 8488751 · Received April 5, 2019

    Report

    Report Number
    3003772750-2019-00003
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    March 11, 2019
    Report Date
    April 5, 2019
    Manufacturer
    SYNERON MEDICAL LTD.
    Product Code
    PDZ
    PMA / PMN Number
    K103338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION BY THE PLANT.

    Description of Event or Problem · 1

    CLINIC REPORTED TO TECHNICAL SUPPORT THAT A (B)(6) YEAR OLD FEMALE PRESENTED FOR ENDOVENOUS ABLATION FOR INCOMPETENT RIGHT GREAT SAPHENOUS VEIN (GSV). THE INCOMPETENT VEIN WAS MAPPED AND MARKED WITH ULTRASOUND. ACCESS WAS OBTAINED ABOVE THE LEVEL OF THE KNEE. APPROXIMATELY 19 CM OF THE VEIN HAD BEEN SUCCESSFULLY TREATED, LASER WAS SET TO 1 MM/SECOND AUTOMATIC WITHDRAWAL AND THE LASER TIP WAS CLEARLY VISUALIZED WITHIN THE VEIN. THE GUIDING LIGHT BECAME VISIBLE AT THE ACCESS POINT AND WHAT APPEARED TO BE THE LASER TIP POPPED OUTSIDE THE SKIN. INSPECTION OF THE LASER TIP REVEALED THE LASER FIBER HAD FRACTURED INSIDE THE PATIENT AND AN ESTIMATED 9-10 CM OF GLASS FIBER REMAINED WITHIN THE PATIENT'S SAPHENOUS VEIN. PATIENT WAS SENT TO AN INTERVENTIONAL RADIOLOGIST WHO PERFORMED AN ULTRASOUND AND THEN A PHLEBECTOMY OF THE REMAINING GSV ON (B)(6) 2019. WHILE REMOVING THE VEIN, THE LASER FIBER POPPED OUTSIDE THE VEIN INTO THE VASCULAR SPACE AND COULD NOT BE ACCESSED THROUGH THE INCISION, SO PATIENT WAS CLOSED AND FIBER LEFT WITHIN SAPHENOUS COMPARTMENT. SUBSEQUENTLY, THE PATIENT SAW A VASCULAR SURGEON AND HAD A CT SCAN ON (B)(6) 2019, LOCALIZING THE FIBER WITHIN THE VEIN. THE PATIENT WAS SCHEDULED FOR OPERATIVE PROCEDURE ON (B)(6) 2019 TO HAVE THE REMAINING LASER FIBER REMOVED BY VASCULAR SURGEON. IT WAS REPORTED BY THE CLINIC THAT THE PATIENT IS EXPECTED TO HEAL AND THAT SCARRING WILL BE LIKELY. ADDITIONAL INFORMATION SOLICITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281890 COOLTOUCH ND: YAG SURGICAL LASER PDZ SYNERON MEDICAL LTD. NS 160-15W

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R