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	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on march 3, 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.The laser unit used was an auriga xl laser console with laser settings of 2.2 joules and 18 hertz.It was reported, during the procedure, after three firings, the fiber was not working well.It appeared it was almost broken in the part closer to the connector of the laser.The procedure was completed with another lighttrail single use 600um laser fiber.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 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.The laser unit used was an auriga xl laser console with laser settings of 2.2 joules and 18 hertz.It was reported, during the procedure, after three firings, the fiber was not working well.It appeared it was almost broken in the part closer to the connector of the laser.The procedure was completed with another lighttrail single use 600um laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0401 captures the reportable event of fiber break.Block h10: 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 311 cm from the tip of the fiber connector to the end of the fiber body.The exposed glass measured 6 mm and had a minimal amount of degradation.Examination under magnification confirmed the pattern of the tip was consistent with normal degradation.There was no 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".No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that there was no light from sma connector, indicating a fracture within the fiber connector, and the exposed glass tip had normal degradation.Fibers are consumable and intended to degrade with use.It was 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.

• 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: 11571600
• Report Number: 3005099803-2021-01313
• Device Sequence Number: 3599280
• 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,Followup
• Report Date (Section B): 05/06/2021

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: 10/23/2022
• Device Model Number: M0068F64540
• Device Catalogue Number: 6454
• Device Lot Number: 0026641282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1