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

Model Number	M0068F64640
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the error message: failure 1103 was displayed.Three fibers were used, and due to multiple failures, the patient's procedure had to be cancelled and postponed.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
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.No manufacturing deviations were noted that could have contributed to the event reported.A labeling review was performed on the device instructions for use (ifu).The ifu cited: set the laser treatment parameters as instructed in the laser console user manual and within the appropriate power level for the fiber.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during a procedure, the error message: failure 1103 was displayed.Three fibers were used, and due to multiple failures, the patient procedure had to be cancelled and postponed.Patient was under general anesthesia.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.
Additional Manufacturer Narrative
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.No manufacturing deviations were noted that could have contributed to the event reported.A labeling review was performed on the device instructions for use (ifu).The ifu cited: set the laser treatment parameters as instructed in the laser console user manual and within the appropriate power level for the fiber.Based on the information available the cause that contributed to the reported event cannot be established.
Event or Problem Description
It was reported that during a procedure, the error message: failure 1103 was displayed.Three fibers were used, and due to multiple failures, the patient's procedure had to be cancelled and postponed.Patient was under general anesthesia, patient outcome unknown.This event is being reported for aborted/cancelled procedure with a patient under general anesthesia.

• 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: 23865368
• Report Number: 2124215-2025-92320
• Device Sequence Number: 19988374
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: (01)08714729939801(17)260222(10)37531360
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: 02/22/2026
• Device Model Number: M0068F64640
• Device Catalogue Number: M0068F64640
• Device Lot Number: 0037531360
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 12/22/2025; 03/27/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/16/2026; 04/21/2026
• Date Device Manufactured: 09/24/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LIGHTTRAIL? SINGLE USE LOT 0036970787.; LIGHTTRAIL? SINGLE USE LOT 0036970787.; LIGHTTRAIL? SINGLE USE LOT 0036970787.; LIGHTTRAIL? SINGLE USE LOT 0037531360.; LIGHTTRAIL? SINGLE USE LOT 0037531360.; LIGHTTRAIL? SINGLE USE LOT 0037531360.
• Patient Sex: Unknown