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

Model Number	M0068F64540
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: the returned lighttrail single use 600um laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The piece measured 310.5 cm from the tip of the sma connector to the end of the fiber body.The exposed glass tip measured 6 mm and appeared in good condition.There was dim and distorted light from the sma connector, 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.Additionally, the aim beam was observed to be weak and diminished.No other problems with the device were noted.The reported event of fiber degraded was not confirmed.The analysis of the returned device revealed that the exposed glass tip was observed in good condition.Light from the sma connector was dim and distorted, indicating a likely fracture within the fiber connector.Fibers are consumable and intended to degrade with use.Although the reported complaint of fiber degraded was not able to be confirmed, it is likely that procedural handling of the fiber during set-up or use contributed to the fracture within the fiber connector.Review and analysis of all available information indicated that the 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.
Event or Problem Description
It was reported to boston scientific on april 14, 2021 that a lighttrail single use 600um laser fiber was used in a holmium laser enucleation of the prostate (holep) procedure performed on (b)(6) 2021.Reportedly, the laser unit used was an auriga xl laser console with the laser settings of 2200 millijoules and 18 hertz.During the procedure, after 10 minutes of using, the fiber stopped working.No energy was coming out of the tip.The procedure was completed with another lighttrail single use 600um laser fiber.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of the laser fiber broken within the connector.

• 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
• MDR Report Key: 12127942
• Report Number: 3005099803-2021-03167
• Device Sequence Number: 19918905
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: 12/02/2022
• Device Model Number: M0068F64540
• Device Catalogue Number: 6454
• Device Lot Number: 0026799051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1