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

Model Number	M0068F64640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the fiber broke.Boston scientific has been unable to obtain additional information regarding the patient outcome, despite good faith efforts.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on the information available, the cause that contributed to the reported event cannot be established; a conclusion code of cause not established was assigned to this investigation.
Additional Manufacturer Narrative
Update to block d4: model number, lot number, catalog number and expiration date.Update to block g1: mfr site address, city, zip and country.Upon receipt of the fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual examination of the fiber found the fiber was received in two pieces; the fiber was broken.Microscopic examination noted that the fiber tip was good/unused, and the connector has no defects.Functional test indicated fiber message, please connect fiber.Please dispose applicator after usage.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 completed and states that, immediately discontinue use if breaks or fractures appear in the laser fiber.These breaks or fractures may allow undirected emission of laser energy, rendering the distal tip useless and causing harm to surrounding tissues.Carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket/fiber or other particulates/pieces, or other visual damage.If the fiber appears damaged, do not use the device.If it is an unused 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 there was an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during a procedure, the fiber broke.Boston scientific has been unable to obtain additional information regarding the patient outcome, despite good faith efforts.

• 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: 19608612
• Report Number: 2124215-2024-36772
• Device Sequence Number: 15083093
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: (01)08714729939801(17)250412(10)32717893
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 04/12/2025
• Device Model Number: M0068F64640
• Device Catalogue Number: M0068F64640
• Device Lot Number: 0032717893
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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