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

Model Number	M0068F64540
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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 february 20, 2020 that a lighttrail single use 600um laser fiber was used in a lithotripsy procedure in the ureter performed on (b)(6) 2020.According to the complainant, during the procedure, there was no energy coming out from the laser fiber.Reportedly, the fiber was noted to be layered on one section.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 e1: initial reporter phone (b)(6).Block h6: problem code 1454 captures the reportable event of fiber peeled/delaminated.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 fiber body separated 34.6 cm from the tip of the sma connector.The analysis of the returned device found that the fiber was broken, and there was damage on the jacket.The fiber body measured 304 cm in length and the exposed glass tip measured approximately 6 mm and appeared fractured.Examination under magnification confirmed the pattern on the tip was consistent with a fracture.Light was not observed from the sma connector due to the received condition of the device.The remainder of the distal tip was not returned.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device observed that the fiber was separated from the sma connector, damage to the fiber jacket near the connector and tip fracture.Damage within the connector of the device can result in complete inability for the fiber to fire.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.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 directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on february 20, 2020 that a lighttrail single use 600um laser fiber was used in a lithotripsy procedure in the ureter performed on (b)(6) 2020.According to the complainant, during the procedure, there was no energy coming out from the laser fiber.Reportedly, the fiber was noted to be layered on one section.The procedure was completed with another lighttrail single use 600um 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
• MDR Report Key: 9922469
• Report Number: 3005099803-2020-01484
• Device Sequence Number: 3272481
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2020

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: 05/16/2021
• Device Model Number: M0068F64540
• Device Catalogue Number: 69267
• Device Lot Number: 0024029030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1