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

Model Number	M0068F64540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) captures the reportable event of fiber break.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 (b)(6) 2022 that a lighttrail single use laser fiber was used during a holmium laser enucleation of the prostate (holep) procedure to treat benign prostatic hyperplasia in the prostate, performed (b)(6) 2022.The laser unit used was an auriga xl laser console with a laser setting of 18 hertz and 2.2 joules.Halfway through the surgery, the laser fiber was broken near the connector.No fiber fragments fell inside the patient.The procedure was completed with another lighttrail single use 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 laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in two pieces.The first laser fiber piece was the whole sma connector, which measured 4.5 cm.The second laser fiber piece was the fiber body and measured 310.2 cm.The exposed glass tip measured 6 cm and appeared degraded.Examination under magnification confirmed the pattern of the tip was consistent with normal degradation.A functional evaluation revealed that the light from the sma connector was distorted, indicating that there was a fracture within the connector.No other problems with the device were noted.The reported event of the lighttrail single use laser fiber broke was confirmed.Laser fibers are consumable devices and expected to degrade with use.It is likely that procedural handling of the device during set up or use contributed to the fiber body separation from the sma connector.Additionally, light from the sma connector was distorted, indicating that there was a fracture within the connector.Review and analysis of all available information indicated that 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.
Event or Problem Description
It was reported to boston scientific corporation on may 25, 2022 that a lighttrail single use laser fiber was used during a holmium laser enucleation of the prostate (holep) procedure to treat benign prostatic hyperplasia in the prostate, performed on (b)(6) 2022.The laser unit used was an auriga xl laser console with a laser setting of 18 hertz and 2.2 joules.Halfway through the surgery, the laser fiber was broken near the connector.No fiber fragments fell inside the patient.The procedure was completed with another lighttrail single use laser fiber.There were no patient complications reported as a result of this event.

• 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 ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14718191
• Report Number: 3005099803-2022-03289
• Device Sequence Number: 2175478
• 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,Followup
• Report Date (Section B): 07/14/2022

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: 02/25/2024
• Device Model Number: M0068F64540
• Device Catalogue Number: 6454
• Device Lot Number: 0029205594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2022
• 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