BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGHTTRAIL REUSABLE

    MDR report key: 7485521 · Received May 3, 2018

    Report

    Report Number
    3005099803-2018-01407
    Event Type
    Malfunction
    Date Received
    May 3, 2018
    Date of Event
    April 10, 2018
    Report Date
    April 10, 2018
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GEX
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT PATIENT AGE IS UNKNOWN; HOWEVER THE PATIENT WAS REPORTED TO BE OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (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 · 1

    INVESTIGATION RESULTS ONE LIGHTTRAIL REUSABLE 600 M LASER FIBER WAS RECEIVED FOR EVALUATION. VISUAL ANALYSIS REVEALED THAT THE EXPOSED GLASS FIBER TIP MEASURED APPROXIMATELY 1.0 MM. ADDITIONAL EXAMINATION UNDER MAGNIFICATION REVEALED THAT THE PATTERN ON THE FIBER FACE WAS CONSISTENT WITH A FRACTURE INDICATING THAT THE TIP OR PORTION OF THE TIP DETACHED. THE CONNECTOR DETACHED FROM THE FIBER DURING ANALYSIS INDICATING THAT THE FIBER WAS BROKEN WITHIN THE CONNECTOR. 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.

    Description of Event or Problem · 1

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-01407 AND 3005099803-2018-01408 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT TWO LIGHTTRAIL REUSABLE 600UM LASER FIBERS WERE USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL 3022 WITH LASER SETTINGS BETWEEN 2KJ, 3KJ AND 15HZ,18HZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST LASER FIBER WAS USED FOR ABOUT ONE AND A HALF HOUR WHEN THE LASER FIBER BURNED NEAR THE CONNECTOR AND IT BROKE OFF. THIS WAS THE FIRST TIME THE LASER FIBER WAS USED (CAPTURED IN MFR. # 3005099803-2018-01407). A SECOND FIBER WAS USED WITH THE SAME LASER SETTINGS. THE LASER FIBER WAS USED FOR FIFTEEN MINUTES AND IT WAS NOTED THAT THE SMA CONNECTOR WAS HOT TO TOUCH (CAPTURED IN MFR. # 3005099803-2018-01408). REPORTEDLY, THE SECOND LASER FIBER WAS RE-STERILIZED ONCE PRIOR TO THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SECOND LIGHTTRAIL REUSABLE 600UM 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 STABLE.

    Description of Event or Problem · 1

    THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO THE ASSOCIATED MANUFACTURER REPORT NUMBERS 3005099803-2018-01407 AND 3005099803-2018-01408 FOR THE REFERENCED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT TWO LIGHTTRAIL REUSABLE 600 M LASER FIBERS WERE USED IN A HOLMIUM LASER ENUCLEATION OF THE PROSTATE (HOLEP) PROCEDURE IN THE PROSTATE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL 3022 WITH LASER SETTINGS BETWEEN 2KJ, 3KJ AND 15HZ,18HZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST LASER FIBER WAS USED FOR ABOUT ONE AND A HALF HOUR WHEN THE LASER FIBER BURNED NEAR THE CONNECTOR AND IT BROKE OFF. THIS WAS THE FIRST TIME THE LASER FIBER WAS USED (CAPTURED IN MFR. # 3005099803-2018-01407). A SECOND FIBER WAS USED WITH THE SAME LASER SETTINGS. THE LASER FIBER WAS USED FOR FIFTEEN MINUTES AND IT WAS NOTED THAT THE SMA CONNECTOR WAS HOT TO TOUCH (CAPTURED IN MFR. # 3005099803-2018-01408). REPORTEDLY, THE SECOND LASER FIBER WAS RE-STERILIZED ONCE PRIOR TO THIS PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SECOND LIGHTTRAIL REUSABLE 600 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326117 LIGHTTRAIL REUSABLE POWERED LASER SURGICAL INSTRUMENT GEX BOSTON SCIENTIFIC - MARLBOROUGH M006864550 201707331

    Patients

    Seq Age Sex Outcome Treatment
    1