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

Model Number	M006L8405910
Medical Device Problem Codes	Break (1069); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a holmium laser procedure to treat an enlarge prostate, the fiber body overheated and exploded.The physician replaced the fiber, and completed the procedure, without patient complications.
Additional Manufacturer Narrative
The device is not available for analysis; therefore, no physical analysis of the product could be performed.However, the customer provided a photo showing that the connection between the fiber and the console caused the overheating, which ultimately led to the fiber break.The reported device performance allegation can be confirmed.The device history review (dhr) confirmed that the device met all material, assembly and performance specifications.Based on the information available, the most probable cause assigned is cause traced to component failure.
Event or Problem Description
It was reported that during a holmium laser procedure to treat an enlarge prostate, the fiber body overheated and exploded.The physician replaced the fiber, and completed the procedure, without patient complications.

• Brand Name: FLEXIVA PULSE
• 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: 20798340
• Report Number: 2124215-2024-74537
• Device Sequence Number: 12736214
• Product Code: GEX
• UDI-Device Identifier: 08714729978572
• UDI-Public: 08714729978572
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 12/30/2024

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 Expiration Date: 01/11/2026
• Device Model Number: M006L8405910
• Device Catalogue Number: M006L8405910
• Device Lot Number: 0030836745
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/30/2024
• Date Device Manufactured: 01/12/2023
• 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: Male