BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTTRAIL SINGLE USE

    MDR report key: 14939476 · Received July 6, 2022

    Report

    Report Number
    3005099803-2022-03620
    Event Type
    Malfunction
    Date Received
    July 6, 2022
    Date of Event
    May 13, 2022
    Report Date
    October 24, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K111475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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.

    Additional Manufacturer Narrative · 0

    BLOCK H6: MEDICAL DEVICE PROBLEM CODE A0401 CAPTURES THE REPORTABLE EVENT OF FIBER BREAK.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THIS PRODUCT WAS THOROUGHLY ANALYZED IN OUR QUALITY ASSURANCE LABORATORY. VISUAL ANALYSIS IDENTIFIED THE FIBER BODY WAS DETACHED/SEPARATED FROM THE SUB MINIATURE A CONNECTOR, THUS CONFIRMING THE AS REPORTED FIBER BREAK. THE FIBER WAS FUNCTIONALLY TESTED, AND IT REVEALED THAT NO LIGHT FROM THE SUB MINIATURE A (SMA) CONNECTOR, INDICATING A FRACTURE WITHIN THE CONNECTOR. IT IS LIKELY THAT THE PROCEDURAL HANDLING OF THE DEVICE DURING USE CONTRIBUTED TO THE DAMAGE TO THE FIBER. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), THE FIBER MUST BE CAREFULLY INSPECTED FOR KINKS, PUNCTURES, FRACTURES OR OTHER DAMAGE. IF THE FIBER APPEARS DAMAGED, DO NOT USE THE DEVICE. BASED ON THE ANALYSIS RESULTS AND INFORMATION AVAILABLE, THE INTERACTION BETWEEN THE USER AND DEVICE CAUSED OR CONTRIBUTED TO THE OBSERVED FIBER DAMAGE AND REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY PROCEDURE FOR LITHIASIS IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA 30 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 13, 2022 THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY PERFORMED ON A MAY 13, 2022. THE LASER UNIT USED WAS AN AURIGA 30 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. THERE WERE NO FIBER FRAGMENTS FELL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 13, 2022 THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY PERFORMED ON A (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA 30 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. THERE WERE NO FIBER FRAGMENTS FELL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257453 LIGHTTRAIL SINGLE USE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 6464 0029019847

    Patients

    Seq Age Sex Outcome Treatment
    1 Female