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

Model Number 6463

Device Problem Break (1069)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that during a flexible ureteroscopic holmium laser lithotripsy procedure, the filter element at the tip of the fiber was fractured.The procedure was completed with another fiber.No patient complications were reported.

Event Description

It was reported that during a flexible ureteroscopic holmium laser lithotripsy procedure, the filter element at the tip of the fiber was fractured.The procedure was completed with another fiber.No patient complications were reported.

Manufacturer Narrative

Upon return, the device was thoroughly analyzed.During the product analysis, the device was received in one piece however the length in which the device was received is indicative of a fiber break.In addition, the light exiting the connector face was distorted, indicating a connector fracture.Finally, when connected to the console the fiber read that it was used 192 times.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.A review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There was no issue noted with translation, wording, or graphics during the revision of the ifu.There is no evidence that any updates to the document are required at this time.The investigation conclusion code assigned is failure to follow instruction, which indicates problems traced to the user not following the manufacturer's instructions.

• Brand Name: LIGHTTRAIL REUSABLE
• 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 CORPORATION; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18947576
• MDR Text Key: 338189849
• Report Number: 2124215-2024-17145
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/21/2024

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: 6463
• Device Catalogue Number: 6463
• Device Lot Number: 0030106919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 75 KG