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	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the fiber had light coming through and was broken.The procedure was completed with another device.There were no patient complications.
Additional Manufacturer Narrative
B3.Date of event - the exact date of the event was not reported.
Additional Manufacturer Narrative
B3.Date of event - the exact date of the event was not reported.Upon receipt of the fiber at our quality assurance laboratory, the fiber was thoroughly analyzed.The device was received in one piece; light was not exiting the fiber body.It passed the visual, microscopic and functional test.A review of the device instructions for use (ifu) was completed and states to carefully inspect the fiber for kinks, punctures, fractures, a broken tip (flat or ball), jacket or fiber or other particulates or pieces, or other visual damage.If the fiber appears damaged, do not use the device.If it is an unused device, return it to boston scientific for replacement.The device history record (dhr) was reviewed and indicated that the device met all manufacturing specifications.Based on the information available, being unable to confirm the reported complaint a conclusion code of no problem detected was assigned to this investigation.The manufacturer has reviewed all the information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that during the procedure, the fiber had light coming through and was broken.The procedure was completed with another 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: 22100539
• Report Number: 2124215-2025-34479
• Device Sequence Number: 8448029
• Product Code: GEX
• UDI-Device Identifier: 08714729978718
• UDI-Public: (01)08714729978718(17)271128(10)35382824
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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: 0035382824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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