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

Model Number	M006L8406960
Medical Device Problem Codes	Break (1069); Nonstandard Device (1420)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the distal end of the fiber broke off in the patient's kidney and was irretrievable.There was no report of patient or procedure outcome.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual inspection found that the fiber body and the tip was broken.The analysis of the returned fiber found that the ball tip was broken off in addition to the fiber body was broken.Microscopic inspection found that the connector was in good condition.The reported event of fiber break was confirmed.A review of the device instructions for use (ifu) was completed and states to 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.Care should be exercised with the glass tip to avoid severe impact or side stresses that may fracture the tip.Also, avoid repassing the flexiva pulse id tractip laser fiber through a deflected scope after energy has been applied to the treatment area as the tractip may not maintain its original shape and may cause scope damage.The device history record (dhr) review confirmed that the device met all manufacturing specifications; therefore, the failure was unlikely related to manufacturing.It is likely that procedural conditions of the device during set-up or use contributed to the fiber body and tip break.A fiber could be damaged or kinked during setup and fully break once laser energy is applied.The investigation.The patient code of unretrieved device fragments is anticipated in nature as per ifu and hazard analysis, and it is a known inherit risk of the device.The investigation conclusion code assigned is cause traced to component failure, indicating that an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during the procedure, the distal end of the fiber broke off in the patient's kidney and was irretrievable.There was no report of patient or procedure outcome.

• 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: 23375433
• Report Number: 2124215-2025-75630
• Device Sequence Number: 8915978
• Product Code: GEX
• UDI-Device Identifier: 08714729978718
• UDI-Public: (01)08714729978718(17)280618(10)36791080
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: 0035886387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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