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

Model Number	M0068F64500
Medical Device Problem Codes	Degraded (1153); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
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 march 18, 2021 that a lighttrail single use 230um laser fiber was used in a flexible ureteroscopy (furs) procedure performed on (b)(6) 2021.The laser unit used was an auriga 30 laser console.During the procedure, as soon as the fiber came into view on the scope it was noted that the laser fiber tip was damaged.The physician was able to fire the fiber but was unsatisfied with the efficiency.The procedure was completed with another lighttrail single use 230um laser fiber.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific, that a lighttrail single use 230um laser fiber was used in a flexible ureteroscopy (furs) procedure.Performed on (b)(6) 2021.The laser unit used, was an auriga 30 laser console.During the procedure, as soon as the fiber came into view on the scope.It was noted, that the laser fiber tip was damaged.The physician was able to fire the fiber, but was unsatisfied with the efficiency.The procedure was completed with another lighttrail single use 230um laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406, captures the reportable event of tip/face deformation.Block h10: investigation results: the returned lighttrail single use 230um laser fiber was analyzed.And a visual evaluation noted, that it was returned in one piece.The fiber measured 308 cm from the tip of the sma connector to the end of the exposed glass tip.The exposed glass measured 1 mm and appeared degraded.Examination under magnification confirmed, the pattern of the tip is consistent with normal degradation.When connected to the laser console, the following message was displayed "fiber may not be used anymore.Please connect new fiber".Light from the sma connector was bright and round, indicating no fracture within the fiber connector.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed, that the exposed glass tip had normal degradation.Light from the sma connector was bright and round, indicating no fractures within the connector.The exposed glass tip is intended to degrade with use.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: 11637264
• Report Number: 3005099803-2021-01616
• Device Sequence Number: 17018334
• Product Code: GEX
• UDI-Device Identifier: 08714729939764
• UDI-Public: 08714729939764
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/20/2021

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: 10/07/2022
• Device Model Number: M0068F64500
• Device Catalogue Number: 6450
• Device Lot Number: 0026435975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 04/27/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1