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

Model Number	M006L8406910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the fiber tip broke off inside the patient and was retrieved using a basket.The procedure was completed using another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Block b3: date of event was approximated to december 1, 2025, based on the date the manufacturer became aware of the event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to december 1, 2025, based on the date the manufacturer became aware of the event.The device is not available for analysis; therefore, no physical analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without product return and proper evaluation of the device, the most probable cause that contributed to the event remains unknown.A review of device history was not performed as the lot number is unknown, and ship history review did not return any probable lots.A labeling review was performed on the device instructions for use (ifu).The ifu cited: in soft tissue applications, it is helpful to move the distal tip back and forth or side to side to prevent the tip from sticking to tissue.Care should be exercised with the glass tip to avoid severe impact or side stresses that may fracture the tip.Based on the information provided, unable to exclude device problem is selected as the most probable cause for the complaint, as the investigation findings do not clearly confirm the presence or absence of the reported problem with the device.
Event or Problem Description
It was reported that during procedure, the fiber tip broke off inside the patient and was retrieved using a basket.The procedure was completed using another of the same device.There were no patient complications.

• 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; 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: 24069323
• Report Number: 2124215-2026-02452
• Device Sequence Number: 21403163
• Product Code: GEX
• UDI-Device Identifier: 08714729978671
• UDI-Public: (01)08714729978671
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: M006L8406910
• Device Catalogue Number: M006L8406910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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