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

Model Number	M0068F64500
Medical Device Problem Codes	Connection Problem (2900); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
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 a supplemental mdr will be filed.
Event or Problem Description
Note: this manufacturer report pertains to an auriga xl 4007 console and two lighttrail single use laser fibers that were used during the same procedure.Manufacturer report number 3005099803-2021-05600, manufacturer report number 3005099803-2021-05601, and for the associated device information.It was reported to boston scientific corporation that an auriga xl 4007 console and two lighttrail single use laser fibers were used during a flexible ureteroscopy procedure to treat kidney stones on (b)(6) 2021.During the procedure, when the physician was about to use the fiber, error code 1103- "fiber identification failed" displayed on the auriga console, making it impossible to use the first laser fiber.A second lighttrail single use laser fiber was opened for the procedure, however this laser fiber was also not able to be used due to the console error message.The procedure was unable to be completed due to this event.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that an auriga xl 4007 console and two lighttrail single use laser fibers were used during a flexible ureteroscopy procedure to treat kidney stones on (b)(6) 2021.During the procedure, when the physician was about to use the fiber, error code 1103- "fiber identification failed" displayed on the auriga console, making it impossible to use the first laser fiber.A second lighttrail single use laser fiber was opened for the procedure, however this laser fiber was also not able to be used due to the console error message.The procedure was unable to be completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf medical device code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: 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 a supplemental mdr will be filed.
Event or Problem Description
Note: this manufacturer report pertains to an auriga xl 4007 console and two lighttrail single use laser fibers that were used during the same procedure.Please refer manufacturer report number 3005099803-2021-05600, manufacturer report number 3005099803-2021-05601, and manufacturer report 3005099803-2021-05602 for the associated device information.It was reported to boston scientific corporation that an auriga xl 4007 console and two lighttrail single use laser fibers were used during a flexible ureteroscopy procedure to treat kidney stones on (b)(6) 2021.During the procedure, when the physician was about to use the fiber, error code 1103- "fiber identification failed" displayed on the auriga console, making it impossible to use the first laser fiber.A second lighttrail single use laser fiber was opened for the procedure, however this laser fiber was also not able to be used due to the console error message.The procedure was unable to be completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf medical device code a27 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: the returned lighttrail single use laser fiber was analyzed and a visual evaluation noted that the device was returned in one piece.The fiber measures 310.2 cm from the end of the connector to the end of the exposed glass tip.The exposed glass tip measured 6 mm and appeared in good condition.Light from the sma connector was bright and round, indicating no fractures within the fiber connector.A functional evaluation found that when the sma connector was connected to the laser console, the fiber rfid was able to be recognized and the console message was "please dispose applicator after usage." the reported event of fiber connection issue was not confirmed.Based on all available information, it was observed that the lighttrail single use laser fiber was able to connect to and the rfid was able to be recognized by the console.Additionally, the exposed glass tip was observed in good condition.The complaint could not be confirmed and there is evidence from the product analysis indicated there was no issue with the fiber connection to the console.Therefore, the most probable cause assigned is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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; cork IRELA ND; EI IRELAND
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12739864
• Report Number: 3005099803-2021-05602
• Device Sequence Number: 4099494
• Product Code: GEX
• UDI-Device Identifier: 08714729939764
• UDI-Public: 08714729939764
• 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,Followup
• Report Date (Section B): 12/28/2021

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: 09/24/2022
• Device Model Number: M0068F64500
• Device Catalogue Number: 6450
• Device Lot Number: 0026315222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 12/06/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/24/2021; 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2020
• 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