MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA PULSE ID; POWERED LASER SURGICAL INSTRUMENT

Model Number	2130-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a laser lithotripsy procedure to treat kidney stones, the end of the fiber that screws into the console broke off when they were trying to connect the fiber to the console.This occurred when they were starting the lithotripsy portion of the procedure.The fiber was replaced, and the procedure was completed using a second fiber.There were no patient complications.
Event or Problem Description
It was reported that during a laser lithotripsy procedure to treat kidney stones, the end of the fiber that screws into the console broke off when they were trying to connect the fiber to the console.This occurred when they were starting the lithotripsy portion of the procedure.The fiber was replaced, and the procedure was completed using a second fiber.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection of the fiber found that the fiber body was broken, the connector was separated from the body and was not returned.The device history record (dhr) was reviewed and indicated that the device met all manufacturing specifications.A review of the device instructions for use (ifu) was completed and states that 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 causing harm to surrounding tissues and also, states to carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket or fiber or other particulates or pieces, or other visual damage.If the fiber appears damaged, do not use the device.If it is an unused device, return it to boston scientific for replacement.It is probable that the fiber break occurred during procedural handling during set-up or use.Based on the information available.A conclusion code of cause traced to component failure was assigned to this investigation, indicating there was an expected or random component failure without any design or manufacturing issue.

• Brand Name: FLEXIVA PULSE ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 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: 21858199
• Report Number: 2124215-2025-23301
• Device Sequence Number: 4709198
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: (01)08714729978725(17)280205(10)35784136
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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 Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0035784136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown