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

Model Number	M006L8406960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the fiber tip was broken in the renal calyx.It was noted that the laser tip was removed intact using a basket.There was no report of patient complications.
Event or Problem Description
It was reported that during the procedure, the fiber tip was broken in the renal calyx.It was noted that the laser tip was removed intact using a basket.The procedure was completed using another of the same device.There were no patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.The product record review (prr) results detailed in the prr table did not determine the probable cause of complaint.A review of the device history record (dhr) confirmed that the device met specification prior to shipping.No manufacturing deviations were noted that could have contributed to the event reported.A risk review was completed and confirmed that the event of "detached/broke inside patient" was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.A labeling review was performed on the device instructions for use (ifu).The ifu cited to 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 the manufacturer for a replacement.Based on the information available, the conclusion code "cause not established" has been assigned as the most probable cause for the complaint.

• 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: 24868061
• Report Number: 2124215-2026-20008
• Device Sequence Number: 8951699
• Product Code: GEX
• UDI-Device Identifier: 08714729978718
• UDI-Public: (01)08714729978718(17)281001(10)37599885
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M006L8406960
• Device Catalogue Number: M006L8406960
• Device Lot Number: 0037599885
• 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: 03/30/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/22/2026
• Date Device Manufactured: 10/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown