BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER

    MDR report key: 7523318 · Received May 17, 2018

    Report

    Report Number
    3005099803-2018-01521
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    April 24, 2018
    Report Date
    April 25, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    UDI-DI
    08714729808176
    PMA / PMN Number
    K110685
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE FLEXIVA 200 TRACTIP LASER FIBER WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION REVEALED THAT THE EXPOSED GLASS FIBER TIP MEASURED APPROXIMATELY 3.5 MM AND APPEARED UNUSED. ADDITIONAL EXAMINATION UNDER MAGNIFICATION REVEALED THAT THE TIP WAS SLIGHTLY DEGRADED. THE INVESTIGATOR WAS UNABLE TO EXAMINE THE FIBER FACE WITHIN THE SMA CONNECTOR BECAUSE LIGHT WAS UNABLE TO TRAVEL TO THE FIBER FACE TO ILLUMINATE IT; THIS INDICATED THAT THE FIBER WAS BROKEN WITHIN CONNECTOR WHICH WOULD CAUSE THE SMA CONNECTOR TO HEAT UP. AS A RESULT, THE STRAIN RELIEF BOOT MELTED. THE CONDITION OF THE RETURNED DEVICE CONFIRMS THE EVENT. THE NOTED DAMAGES INDICATE DIFFICULTY WAS EXPERIENCED DURING THE PROCEDURE AND ARE LIKELY DUE TO ANATOMICAL OR PROCEDURAL FACTORS SUCH AS TORTUOUS ANATOMY OR MANEUVERING OF THE DEVICE. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT.  A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS; HOWEVER THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A FLEXIVA 200 TRACTIP LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THE LASER FIBER WAS NOT EMITTING ENOUGH LASER ENERGY. THE OPERATOR OF THE DEVICE UNSCREWED THE LASER FIBER FROM THE CONSOLE AND FOUND THAT THE CONNECTION BETWEEN THE BLACK RUBBER SMA BOOT CONNECTOR AND THE METAL CONNECTOR WAS BROKEN. THE METAL CONNECTOR WAS HOT TO TOUCH AND BURNED THE TECHNICIAN¿S INDEX FINGER. NO TREATMENT WAS REQUIRED TO TREAT THE BURN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 200 TRACTIP LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON APRIL 25, 2018 THAT A FLEXIVA 200 TRACTIP LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS A LUMENIS 100 WATT CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AND INSIDE THE PATIENT, IT WAS NOTED THAT THE LASER FIBER WAS NOT EMITTING ENOUGH LASER ENERGY. THE OPERATOR OF THE DEVICE UNSCREWED THE LASER FIBER FROM THE CONSOLE AND FOUND THAT THE CONNECTION BETWEEN THE BLACK RUBBER SMA BOOT CONNECTOR AND THE METAL CONNECTOR WAS BROKEN. THE METAL CONNECTOR WAS HOT TO TOUCH AND BURNED THE TECHNICIAN¿S INDEX FINGER. NO TREATMENT WAS REQUIRED TO TREAT THE BURN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA 200 TRACTIP LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365362 FLEXIVA (TM) TRACTIP HIGH POWER SINGLE-USE LASER FIBER POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M0068403961 0000005734 08714729808176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other