BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTTRAIL REUSABLE

    MDR report key: 14946538 · Received July 7, 2022

    Report

    Report Number
    3005099803-2022-03657
    Event Type
    Malfunction
    Date Received
    July 7, 2022
    Date of Event
    June 15, 2022
    Report Date
    October 20, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER ADDRESS: (B)(6). (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

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS FIBER UNDERWENT A THOROUGH ANALYSIS. VISUAL ANALYSIS OF THE OF THE RETURNED FIBER IDENTIFIED THE FIBER WAS IN TWO PIECES. THE EXPOSED GLASS TIP WAS DEGRADED; HOWEVER, EXAMINATION UNDER MAGNIFICATION CONFIRMED A PATTERN ON THE TIP CONSISTENT WITH NORMAL DEGRADATION. LASER FIBERS ARE CONSUMABLE DEVICES AND EXPECTED TO DEGRADE WITH USE. THE LIGHT FROM THE SUB MINIATURE A (SMA) CONNECTOR WAS BRIGHT AND ROUND INDICATING THERE WAS NO FRACTURE WITHIN THE CONNECTOR. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED ALLEGATION OF A FIBER BREAK WAS CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A LIGHTTRAIL REUSABLE LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE TO TREAT STONES IN THE LEFT URETER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA LASER CONSOLE WITH LASER SETTINGS OF 12 HERTZ AND 300 MILLIJOULES. DURING THE PROCEDURE, THE LASER FIBER SUDDENLY FAILED, THE STAFF TOOK IT OUT OF PATIENT AND REALIZED IT WAS BROKEN. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL REUSABLE 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 15, 2022 THAT A LIGHTTRAIL REUSABLE LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE TO TREAT STONES IN THE LEFT URETER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA LASER CONSOLE ADN THE LASER SETTINGS WERE A FREQUENCY OF 12 HERTZ AND 300 MILLIJOULES. DURING THE PROCEDURE, THE LASER FIBER SUDDENLY FAILED, THE STAFF TOOK IT OUT OF PATIENT AND REALIZED IT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL REUSABLE LASER FIBER. THERE WERE NO FIBER FRAGMENTS FELL INSIDE THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A LITHOTRIPSY TO TREAT STONES IN THE LEFT URETER AT 12 HERTZ AND 300 MILLIJOULES, THE FIBER SUDDENLY DID NOT WORK AS EXPECTED. WHEN THE FIBER WAS REMOVED, IT WAS FOUND TO BE BROKEN. IT WAS NOTED THAT THERE WERE NO FIBER FRAGMENTS INSIDE THE PATIENT BODY. A SECOND FIBER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2672422 LIGHTTRAIL REUSABLE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC CORPORATION 6463 0026996874

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male