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

Model Number	2130-01
Medical Device Problem Codes	Break (1069); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.The fiber device received in one piece; however, a fiber body break was observed, and the pieces were being held together by the fiber jacket.It was noted that when connected to the console the red aim beam was seen escaping the fiber break location.The reported event was not confirmed.The device instructions for use (ifu) indicates that the ifu contains appropriate instructions and warnings for use.The observed condition of the fiber body break likely occurred due to procedural handling of the device during set up.It is probable that a partial body break or kink could have occurred during insertion into the scope and lead to the break.The ifu instructs the user to carefully inspect the fiber for kinks, punctures, fractures or other damage.If the fiber appears damaged, do not use the device.Return it to boston scientific for replacement.Additionally, activate the laser aiming beam, adjust aiming beam brightness, and verify it is not dim or misshapen to confirm the laser fiber functions as intended.Hold the fiber tip to a non-reflective surface and ensure that a circular-colored spot appears.If the spot is dim, not visible, or misshapen, confirm console settings are correct, and if so, do not use and return the device to boston scientific for replacement.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, upon plugging the device into the laser, the aiming beam was red instead of the expected green.The fiber was replaced to complete the procedure with no patient complications.Analysis of the returned device identified a fiber break.

• 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: 18588069
• Report Number: 2124215-2024-03630
• Device Sequence Number: 15576354
• Product Code: GEX
• UDI-Device Identifier: 08714729978626
• UDI-Public: 08714729978626
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2024

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: 07/29/2025
• Device Model Number: 2130-01
• Device Catalogue Number: 2130-01
• Device Lot Number: 0029861695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2022
• 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