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

Model Number	6464
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a procedure, the fiber would not work as it had broken away from the connector.A new fiber was used to complete the treatment.No patient complications were reported.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The device was received in three pieces; the connector was separated from the fiber body.Visual analysis of the returned fiber identified that the fiber tip was unused and in good condition.There was no light exiting the connector face indicating a connector fracture.A fracture within the connector can occur during procedural handling of the fiber like setup or use.The fiber connector may have developed a microfracture that became larger with use or handling, resulting in an insufficient aiming beam and low laser energy output.In this case the interaction between the connector and console and the connector fracture may have led to connector overheating causing the fiber body to break confirmed via analysis.The device instructions for use (ifu) instructs the user to carefully remove the fiber from the shipping card by removing the connector end first.The ifu then states to uncoil the remainder of the fiber from the shipping card, handle the fiber with care as damage may occur if struck or bent sharply and to inspect and treat the output tip with particular care as it represents the most delicate, easily damaged portion of assembly, do not bend the fiber at sharp angles, fiber failure may result when therapeutic energy is applied as the fiber is deflected beyond the optical limits of total internal reflection.Finally, the ifu instructs the user to carefully inspect the fiber for kinks, punctures, fractures or other damage and, if the fiber appears damaged, do not use the device and in the event of no output energy, the laser fiber connector hub may be hot to touch.Based on analysis result, the investigation conclusion code assigned is cause traced to component failure.
Event or Problem Description
It was reported that, during a procedure, the fiber would not work as it had broken away from the connector.A new fiber was used to complete the treatment.No patient complications were reported.

• 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; 300 boston scientific way; hakidma st 6; marlborough MA 01752 ; EI 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 17993221
• Report Number: 2124215-2023-58705
• Device Sequence Number: 12646769
• Product Code: GEX
• UDI-Device Identifier: 08714729939801
• UDI-Public: 08714729939801
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 12/20/2023

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: 03/16/2025
• Device Model Number: 6464
• Device Catalogue Number: 6464
• Device Lot Number: 0031598456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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