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

Model Number	M0068F64540
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one lighttrail single use 600um laser fiber was returned intact in one piece.The piece measured approximately 309.6 cm from the top of the connector to the tip.Exposed glass portion of the tip measured approximately 3 mm and was fractured.Examination under magnification revealed that the fiber tip was fractured with a portion detached.The remainder of the tip was not returned.Functional analysis revealed that when the fiber was connected to the auriga laser console, the "attach fiber" message disappeared indicating that the fiber was recognized by the console.The console stated "applicator has been used three times." the aiming beam exiting the distal tip is bright, clear, and slightly distorted due to the condition of the tip.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 event.A dhr (device history record) review was performed and device met all manufacturing specifications.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 september 5, 2019 that a lighttrail single use 600um laser fiber was used in a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the laser fiber would not fit in the fiber port.The procedure was completed with another lighttrail single use 600um laser fiber.There was no serious injury nor adverse patient effects as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the laser fiber tip detached.

• 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: 9445952
• Report Number: 3005099803-2019-05718
• Device Sequence Number: 2158671
• Product Code: GEX
• UDI-Device Identifier: 08714729939788
• UDI-Public: 08714729939788
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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: 03/20/2021
• Device Model Number: M0068F64540
• Device Catalogue Number: 69267
• Device Lot Number: 0023881537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1