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	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the fiberglass tip was broken.It was noted that when the laser was first initiated, there was a popping noise, and the tip came off where the green meets the clear.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Upon receipt of the fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.Visual and microscopic inspection found that the fiber tip was broken and connector with no defects.Functional tests were performed and found that the aiming beam was bright and distorted due to tip condition and an error 67 fiber expired was noted.A review of the device instructions for use (ifu) was completed and stated that care should be exercised with the glass tip to avoid severe impact or side stresses that may fractured the tip.A device history record (dhr) was reviewed and indicated that the device met all manufacturing specifications.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 break.This fiber is a ball tip, it is possible that it could have become damaged when passing through the scope and when laser energy was applied broke.Based on the information available, a conclusion code of cause traced to component failure was assigned to this investigation, indicating there was an expected or random component failure without any design or manufacturing issue.
Event or Problem Description
It was reported that during the procedure, the fiberglass tip was broken.It was noted that when the laser was first initiated, there was a popping noise, and the tip came off where the green meets the clear.The procedure was completed with 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; 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: 22331843
• Report Number: 2124215-2025-41991
• Device Sequence Number: 9436718
• Product Code: GEX
• UDI-Device Identifier: 08714729978718
• UDI-Public: (01)08714729978718(17)280219(10)35886393
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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 Model Number: M006L8406960
• Device Catalogue Number: M006L8406960
• Device Lot Number: 0035886393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/05/2025
• 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
• Patient Sex: Unknown