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

Model Number	M0068F64520
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.Medical device problem code (b)(4) captures the reportable investigation result of fiber broken within the connector.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 piece measured 310.4 cm.The exposed glass tip measured 6 cm and appeared in good condition.Functional analysis revealed that there was distorted light from the sma connector, indicating a fracture within the fiber connector.When connected to the laser console, the following message was displayed: "fiber may not be used anymore.Please connect new fiber.No other problems with the device were noted.The reported clinical observations of the fiber suddenly going out was confirmed.It is likely that procedural handling of the fiber during set-up or use contributed to the fracture within the fiber connector.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 directions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a lighttrail single use 365um laser fiber was used in a procedure performed on an unknown date.During the procedure, the laser fiber suddenly went out.The procedure was completed with another lighttrail laser fiber.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information: this event has been deemed reportable based on the investigation finding that the laser fiber was broken within the connector.

• 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: 12673322
• Report Number: 3005099803-2021-05393
• Device Sequence Number: 4233667
• Product Code: GEX
• UDI-Device Identifier: 08714729939771
• UDI-Public: 08714729939771
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 11/02/2022
• Device Model Number: M0068F64520
• Device Catalogue Number: 6452
• Device Lot Number: 0026703924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1