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

Model Number	M0068F64640
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the fiber did not work after 17:46 minutes, 2,8888 watts, 8 joules, and 13603 impulses of use.The customer reported that surgical treatment could not be continued and treatment to the patient was disrupted.There were no patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation is unknown.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, this fiber was thoroughly analyzed.A visual inspection was performed and noted that the fiber received in one piece with no defects to fiber body.Microscopic inspection identified that the fiber tip degraded.The connector had distorted light exiting the face, indicating an internal connector fracture and no aiming beam in functional testing.The complaint was confirmed.It is likely that procedural handling of the fiber during setup or use.This connector fracture can result in an insufficient aiming beam or low laser energy output, up to a complete inability for the fiber to fire.The instruction for use (ifu) states, 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.The device history record review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.Based on review of all information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation.
Event or Problem Description
It was reported that the fiber did not work anymore after 17 minutes, 46 seconds, 2,8888 watts, max 8 joules, 13603 impulses, while the laser delivers the beam.It was noted it was impossible to continue the surgical treatment disruption in the continuity of treating the patient.The procedure was not completed due to this event.There were no report of patient complications reported.This event is being reported for aborted/canceled procedure with a patient under anesthesia or sedation is unknown.

• 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; cork business technology park; 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: 21371826
• Report Number: 2124215-2025-07889
• Device Sequence Number: 20988593
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: (01)08714729939801(17)250810(10)33226591
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 08/10/2025
• Device Model Number: M0068F64640
• Device Catalogue Number: M0068F64640
• Device Lot Number: 0033226591
• 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: 02/03/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/29/2025
• Date Device Manufactured: 01/17/2024
• 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 Age: 82 YR
• Patient Sex: Male
• Patient Weight: 82 KG