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

Model Number	M0068F64500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event - date is approximate.
Event or Problem Description
It was reported that this fiber broke twice during the procedure.No patient complications were reported.
Event or Problem Description
It was reported that this fiber broke twice during the procedure.No patient complications were reported.Boston scientific has been unable to obtain additional information regarding procedure and/or patient outcome to date, despite good faith efforts.
Additional Manufacturer Narrative
B3: date of event - date is approximate.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.A review of the device history record (dhr) confirmed that the device met specification prior to shipping.There was no manufacturing deviations noted that could have contributed to the event reported.A labeling review was performed on the device instructions for use (ifu).The ifu cited: fiber should not be clamped with forceps or other securing instruments as it could result in fiber damage or breakage.Based on the information available the cause that contributed to the reported event cannot be established.

• 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: 23381075
• Report Number: 2124215-2025-74619
• Device Sequence Number: 8815698
• Product Code: GEX
• UDI-Device Identifier: 08714729939764
• UDI-Public: (01)08714729939764(17)251130(10)33440209
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 11/30/2025
• Device Model Number: M0068F64500
• Device Catalogue Number: M0068F64500
• Device Lot Number: 0033440209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 02/16/2024
• 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