MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LIGHTTRAIL? SINGLE USE; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068F64540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure two laser fibers broke.The procedure was completed with a different device.There were no patient complications.This is 1of 2 fiber reports.
Additional Manufacturer Narrative
Note: this report is one of two complaints that pertain to the same event (mfr.Report #.And mfr.Report # 2124215-2025-65342).
Additional Manufacturer Narrative
Note: this report is one of two complaints that pertain to the same event (mfr.Report # and mfr.Report # 2124215-2025-65342).Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection found that the fiber was broken into two pieces.Microscope inspection showed that the tip was degraded.Functional test revealed that there was an error code 1101, stating: fiber may not be used anymore.Connect a new fiber.It is likely that procedural conditions of the device during setup or use contributed to the fiber body break.A fiber could be damaged or kinked during setup and fully break once laser energy is applied.The device history record (dhr) was review and indicated that the device met all manufacturing specifications.A review of the device instructions for use (ifu) was performed and stated to carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device.Return it to boston scientific for replacement.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation indicating an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during procedure, this two laser fiber broke.The procedure was completed with different device.There were no patient complications.This is 1of 2 fiber reports.

• Brand Name: LIGHTTRAIL? SINGLE USE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 23100065
• Report Number: 2124215-2025-64927
• Device Sequence Number: 12933044
• Product Code: GEX
• UDI-Device Identifier: 08714729939788
• UDI-Public: (01)08714729939788(17)260731(10)36925086
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: M0068F64540
• Device Catalogue Number: M0068F64540
• Device Lot Number: 0036925086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown