BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTTRAIL SINGLE USE

    MDR report key: 5685861 · Received May 27, 2016

    Report

    Report Number
    3005099803-2016-01319
    Event Type
    Injury
    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
    Adverse Event
    Yes
    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). 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.

    Additional Manufacturer Narrative · 1

    ONE LIGHT TRAIL 230UM SINGLE-USE LASER FIBER WAS RETURNED FOR ANALYSIS. THE FIBER WAS RECEIVED BROKEN INTO TWO PIECES. THE FIRST PIECE MEASURED APPROXIMATELY 53.5 CM FROM THE BREAK TO THE DISTAL TIP. THE SECOND PIECE MEASURED 254 CM FROM THE TOP OF THE CONNECTOR TO THE BREAK. THE EXPOSED GLASS TIP MEASURED APPROXIMATELY 6.0 MM AND APPEARED USED. ADDITIONAL EXAMINATION UNDER MAGNIFICATION REVEALED THAT THE TIP FACE HAD MINIMAL NORMAL DEGRADATION. FUNCTIONAL ANALYSIS REVEALED THAT THE FIBER WAS RECOGNIZED BY THE LASER CONSOLE AND INDICATED THAT THE SINGLE USE FIBER WAS USED ONE TIME. THE AIMING BEAM EXITING THE DISTAL END OF THE DEVICE WAS BRIGHT, CLEAR AND SCATTERED AND EFFECTIVE TRANSMISSION WAS NOT MEASURED DUE TO FIBER BREAKS. 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. A LABELING REVIEW WAS PERFORMED, AND FROM THE INFORMATION AVAILABLE THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL.

    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 LIGHTTRAIL 230 M 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 LIGHTTRAIL 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 LIGHTTRAIL 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 LIGHTTRAIL 230 M 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

    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 (B)(6) 2016 THAT FOUR LIGHTTRAIL 230LASER FIBERS WERE USED DURING A LITHOTRISPY 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 LIGHTTRAIL 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 LIGHTTRAIL 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 LIGHTTRAIL 230 M 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
    340951 LIGHTTRAIL SINGLE USE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M006864500 201500704

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention