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

Model Number	M0068F64520
Medical Device Problem Codes	Connection Problem (2900); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
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 (b)(6) 2021 that a lighttrail single use 270um laser fiber was used in a lithiasis procedure in the bladder performed on (b)(6) 2021.Reportedly, the laser unit used was an auriga xl laser console.It was reported that during preparation for the procedure, the laser fiber was not recognized when connected to the console.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a27 captures the reportable issue of aborted/cancelled procedure.Block h10: investigation results the returned lighttrail single use 365um laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured 308.4 cm from the tip of the sma connector to the end of the exposed glass tip.The exposed glass tip measured approximately 6 mm and showed signs of minor degradation.Examination under magnification confirms the pattern on the tip is consistent with normal degradation.Light from the sma connector was bright and round, indicating no defects with the fiber within the connector.When connected to the laser console, the following message was displayed: fiber may not be used anymore.Please connect new fiber.No other issues with the device were noted.The reported event was not confirmed.The analysis of the returned device revealed that functional testing of the fiber on the laser console was successful as the rfid chip was identified.The fiber is a single use device and the console indicated the fiber had been previously used.Additionally, the exposed glass tip showed signs of normal degradation under magnification and light from the sma connector was bright and round.Testing with the laser console indicates the fiber rfid was able to be identified and the fiber had reached the maximum permitted applications.Although the reported complaint was not able to be confirmed, it was likely caused by the fiber reaching its use limit.Therefore, the investigation conclusion code selected is end of life problem identified, which indicates problems traced to the device reaching the end of its useful life.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: correction to field b5: describe event or problem based on review of the complaint on (b)(6) 2021.
Event or Problem Description
It was reported to boston scientific corporation on january 29, 2021 that a lighttrail single use 270um laser fiber was used in a lithiasis procedure in the bladder performed on (b)(6) 2021.Reportedly, the laser unit used was an auriga xl laser console.It was reported that during preparation for the procedure, the laser fiber was not recognized when connected to the console.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.**updated information based on the review on march 12, 2021 ** it was reported to boston scientific corporation on january 29, 2021 that a lighttrail single use 365um laser fiber was used in a lithiasis procedure in the bladder performed on (b)(6) 2021.

• 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: 11365039
• Report Number: 3005099803-2021-00625
• Device Sequence Number: 11040923
• Product Code: GEX
• UDI-Device Identifier: 08714729939771
• UDI-Public: 08714729939771
• 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): 03/22/2021

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: 08/31/2022
• Device Model Number: M0068F64520
• Device Catalogue Number: 6452
• Device Lot Number: 0026357187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1