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

Model Number	M0068F64540
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This report pertains to one of two devices that were used in the same procedure.Refer to manufacturer report number mfr.Report # 3005099803-2022-02704 for the first lighttrail reusable laser fiber and mfr report # 3005099803-2022-02703 for the second lighttrail reusable laser fiber.It was reported to boston scientific corporation on (b)(6) 2022 that two lighttrail single use laser fibers were used in a holmium laser enucleation of the prostate (holep) procedure, performed on (b)(6) 2022.The laser unit used was an auriga xl laser console.During the procedure, the two laser fibers would not work.No effect was done in the tissue.The procedure was completed with another lighttrail single use laser fiber.There were no patient complications reported as a result of this event.Note: this event has been deemed reportable based on the investigation finding of laser fiber broken within the connector.
Additional Manufacturer Narrative
(b)(4).Investigation results: the returned lighttrail single use laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The laser fiber measured 309.5 cm from the tip of the connector to the end of the exposed glass tip.The exposed glass measured 6 mm and was in good condition.A functional evaluation revealed that the light from the sma connector appeared distorted, indicating a fracture within the fiber connector.When connected to the laser console, the following message was displayed: fiber may not be used anymore.Please connect new fiber.No other problems with the device were noted.The reported event of the lighttrail single use laser fiber failed to emit energy was confirmed.It is likely that procedural handling of the fiber during set-up or use contributed to the fracture within the fiber connector.A broken fiber within the connector of the device can result in insufficient aiming beam and low laser energy output, up to a complete inability for the fiber to fire.Therefore, the most probable root cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14437981
• Report Number: 3005099803-2022-02703
• Device Sequence Number: 12177081
• Product Code: GEX
• UDI-Device Identifier: 08714729939788
• UDI-Public: 08714729939788
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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: 10/28/2023
• Device Model Number: M0068F64540
• Device Catalogue Number: 6454
• Device Lot Number: 0028534158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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