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

Model Number 6465

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that during a stone lithotripsy procedure, the fiber broke.The fiber was replaced to complete the procedure.No patient complications were reported.

Manufacturer Narrative

Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The fiber device received in one piece and no signs of breakage.During the product analysis, the tip was in good condition and unused.Additionally, there was bright and round light exiting the connector face.The reported event was not confirmed.The device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.A risk review indicates that this is an anticipated failure of the device based on normal use, and therefore it is unlikely that there is an issue with the design of the device.The device instructions for use (ifu) indicates that the ifu contains appropriate instructions and warnings for use.The ifu states that improper use of the device or use of a damaged device may result in severe eye or tissue damage, fire in the treatment room and accidental laser exposure to the treatment room personnel or patient.Do not bend the fiber at sharp angles.If visible light can be seen leaking from the fiber, fiber failure may result when therapeutic energy is applied as the fiber is deflected beyond the optical limits of total internal reflection.Immediately discontinue use if breaks or fractures appear in the laser fiber.These breaks or fractures may allow undirected emission of laser energy, rendering the distal tip useless and potentially causing harm to surrounding tissues.Based on all the available information and objective evidence from the product analysis being unable to confirm the reported complaint, this investigation is being assigned a conclusion code of no problem detected.The manufacturer has reviewed all information and determined this event no longer meets the reporting criteria.

Event Description

It was reported that during a stone lithotripsy procedure, the fiber broke.The fiber was replaced to complete the procedure.No patient complications were reported.

• Brand Name: LIGHTTRAIL TRACTIP
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18983630
• MDR Text Key: 338757480
• Report Number: 2124215-2024-17838
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Model Number: 6465
• Device Catalogue Number: 6465
• Device Lot Number: 0032913418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1