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

Model Number	2130-02
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection found that the fiber was broken, and the connector end was separated from the fiber body.Microscopic inspection showed that the fiber tip had no issues; it appears it was stripped.It is likely the kink occurred after the device was packaged during manufacturing but prior to use of the device by the complainant.Functional testing was performed, and the console displayed the message: applicator has been used 0 times.The device history record (dhr) review confirmed that the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.A review of the device instructions for use (ifu) was completed, the ifu states: 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 further states: carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket/fiber or other particulates/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.A review of the flexiva pulse laser fibers hazard analysis was completed and confirmed that the event of fiber tip broken before use was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, a conclusion code of cause traced to component failure was assigned to this investigation which indicates expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that prior to procedure, the fiber tip was broken off upon opening from sterile packaging.The procedure was completed using another of the same device.There were no patient complications.Analysis of the returned device identified a fiber body broken.

• 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: 25020827
• Report Number: 2124215-2026-22921
• Device Sequence Number: 9497420
• Product Code: GEX
• UDI-Device Identifier: 08714729978725
• UDI-Public: (01)08714729978725(17)280916(10)37469646
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2026

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: 0037469646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• 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