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

Model Number	M0068F64540
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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 (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 laser console with laser settings of 2200 millijoules and 18 hertz.During the procedure, the connector of the laser fiber overheated and eventually breaking the laser fiber.A burning smell was noticed by the or staff.There was no reported burn injury to the user or to the patient.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 august 24, 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 laser console with laser settings of 2200 millijoules and 18 hertz.During the procedure, the connector of the laser fiber overheated and eventually breaking the laser fiber.A burning smell was noticed by the or staff.There was no reported burn injury to the user or to the patient.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 a1005 captures the reportable event of fiber connector overheats.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 two pieces.The first piece was the fiber body and measured 306.2 cm.The second piece was the sma connector only and measured 4.5 cm.The exposed glass tip measured 1 mm and appeared degraded.Examination under magnification confirmed the pattern of the tip was consistent with normal degradation.The fiber body was detached from the sma connector, likely due to overheating.No other problems with the device were noted.The reported event was confirmed.Fibers are consumable and intended to degrade with use.Although the fiber break was confirmed and likely due to the console overheating, the cause for the console component misalignment and subsequent overheating could not be determined.Based on a thorough review of the reported complaint, the most probable cause for this complaint was considered cause not established.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: 12484033
• Report Number: 3005099803-2021-04851
• Device Sequence Number: 3936499
• 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): 10/25/2021

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: 03/24/2023
• Device Model Number: M0068F64540
• Device Catalogue Number: 6454
• Device Lot Number: 0027371147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1