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

Model Number	M006L8405960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt of this fiber at our quality assurance laboratory, the returned fiber was thoroughly analyzed and was received in one piece with no defects.Microscopic inspection was performed and identified that the tip was broken.The connector was good.The aiming beam was bright and distorted due to tip break.The complaint was confirmed.It is likely that procedural conditions, such as physician technique, size and composition of the material being ablated, may have contributed to the fiber tip to breaking off.The instructions for use (ifu) was performed and states; care should be exercised with the glass tip to avoid severe impact or side stresses that may fracture the tip.The device history record review indicates the device met all manufacturing specifications, and therefore the failure was unlikely related to manufacturing.Based on analysis result, the investigation conclusion code assigned is cause traced to component failure.
Event or Problem Description
It was reported that during the procedure, the fiber tip was damaged/separated while inside the body.The broken segment was spontaneously excreted and did not require retrieval.The procedure was completed with this device, and no patient complications were reported.
Event or Problem Description
It was reported that during the procedure, the fiber tip was damaged/separated while inside the body.The broken segment was spontaneously excreted and did not require retrieval.The procedure was completed with this device, and no patient complications were reported.

• 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: 21123664
• Report Number: 2124215-2024-82999
• Device Sequence Number: 15321924
• Product Code: GEX
• UDI-Device Identifier: 08714729978619
• UDI-Public: 08714729978619
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 02/01/2026
• Device Model Number: M006L8405960
• Device Catalogue Number: M006L8405960
• Device Lot Number: 0030971024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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: Unknown