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

Model Number	M006L8406940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the tip of the laser fiber broke at the exposed glass tip.The same event occurred with two fibers.The procedure was completed using another of the same device.There were no patient complications.This event is for the second fiber.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The product record review results detailed in the prr table did not determine probable cause.A review of the device history record (dhr) confirmed that the device met specification prior to shipping.There was no manufacturing deviations noted that could have contributed to the event reported.A labeling review was performed on the device instructions for use (ifu).The ifu cited that, care should be exercised with the glass tip to avoid severe impact or side stresses that may fracture the tip.Based on the information available, the conclusion code "unable to exclude device problem" has been assigned as the most probable cause.
Event or Problem Description
It was reported that during procedure, the tip of the laser fiber broke at the exposed glass tip.The same event occurred with two fibers.The procedure was completed using another of the same device.There were no patient complications.This event is for the second fiber.

• 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: 23882797
• Report Number: 2124215-2025-92798
• Device Sequence Number: 17326488
• Product Code: GEX
• UDI-Device Identifier: 08714729978701
• UDI-Public: (01)08714729978701(17)280604(10)36682072
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K210925
• 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): 02/17/2026

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: M006L8406940
• Device Catalogue Number: M006L8406940
• Device Lot Number: 0036682072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/17/2026
• Date Device Manufactured: 06/05/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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