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

Model Number	M0068F64640
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection found that the fiber body was broken into two pieces.Microscopic test shows that tip and connector were in good condition.Functional test indicated a message: please dispose applicator after usage.A device history record (dhr) was review and confirmed that the device met all manufacturing specifications.A review of the device instructions for use (ifu) was completed and cited that fiber should not be clamped with forceps or other securing instruments as it could result in fiber damaged or breakage.It is likely that procedural conditions of the device during set up or use contributed to the fiber body break.A fiber could be damaged or kinked during set up and fully break once laser energy is applied.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation indicating there was an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during the procedure, the fiber was damaged.The procedure was completed.There was no report of patient complications.Analysis of the returned device identified a broken fiber.

• 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 CORK LIMITED; business & technology park; model farm road; cork ; EI
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24020772
• Report Number: 2124215-2026-01542
• Device Sequence Number: 18380626
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: (01)08714729939801(17)260531(10)35145395
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: 05/31/2026
• Device Model Number: M0068F64640
• Device Catalogue Number: M0068F64640
• Device Lot Number: 0035145395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2024
• 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: Female