BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTTRAIL SINGLE USE

    MDR report key: 5685895 · Received May 27, 2016

    Report

    Report Number
    3005099803-2016-01525
    Event Type
    Malfunction
    Date Received
    May 27, 2016
    Date of Event
    April 21, 2016
    Report Date
    May 3, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    K111475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOT NUMBER DOES NOT MATCH ANY KNOWN LOT NUMBERS FOR THE DEVICE; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. (B)(4). MFG SITE NAME: (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF FOUR DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT #3005099803-2016-01319, 3005099803-2016-01523, 3005099803-2016-01524 AND 3005099803-2016-01525 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 3, 2016 THAT FOUR LIGHT-TRAIL 230LASER FIBERS WERE USED DURING A LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2016. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL CONSOLE. . ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST LASER FIBER (CAPTURED BY MNF REPORT #3005099803-2016-01319) BROKE INSIDE THE PATIENT AFTER 141 COUNTS ON THE AURIGA CONSOLE. THE BROKEN FRAGMENT WAS RETRIEVED FROM THE PATIENT. THE PHYSICIAN ATTEMPTED TO USE A SECOND LIGHT-TRAIL LASER FIBER (CAPTURED BY MNF REPORT #3005099803-2016-01523) BUT THE FIBER ALSO BROKE AFTER 141 COUNTS AND BROKEN FRAGMENT WAS RETRIEVED FROM THE PATIENT. ADDITIONALLY, 2 MORE LIGHT-TRAIL LASER FIBERS WERE OPENED AND ALSO BROKE UPON TESTING PRIOR TO USE IN THE PATIENT (CAPTURED BY MNF REPORT #3005099803-2016-01524 AND 3005099803-2016-01525). THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHT-TRAIL 230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
    341520 LIGHTTRAIL SINGLE USE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M006864500 201500704

    Patients

    Seq Age Sex Outcome Treatment
    1