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

Model Number	2130-01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a lithotripsy procedure, the fiber had a ring omitting around before ball tip.The procedure was completed with a different device with no patient complications.This report refers to the third fiber.
Additional Manufacturer Narrative
Report number 2124215-2024-56797 refers to the first fiber.Report number 2124215-2024-56800 refers to the second fiber.Report number 2124215-2024-56815 refers to the fourth fiber.
Event or Problem Description
It was reported that during a lithotripsy procedure, the fiber had a ring omitting around before ball tip.The procedure was completed with a different device with no patient complications.This report refers to the third fiber.
Additional Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the fiber underwent a thorough analysis.The fiber was received in one piece; the fiber body has no defects or breaks.During the product analysis the tip was in good condition and connector has no defects, light exiting the connector face.Additionally, the aim beam was bright and round.With all the available information the reported event was not confirm.The device instructions for use (ifu) indicates that inspect and treat the output tip with particular care as it represents the most-delicate, easily damaged portion of the assembly.Based on the investigation, when performing more visual tests the fiber jacket was stripped off the fiber and there was no breakage and once the fiber jacket was removed there was no light exiting the area just before the ball tip.In addition, functional test found that the fiber transmission was good.Based on all the available information objective evidence from the product analysis being unable to confirm the reported complaint, a conclusion code of no problem detected was assigned to this investigation.Report number 2124215-2024-56797 refers to the first fiber.Report number 2124215-2024-56800 refers to the second fiber.Report number 2124215-2024-56815 refers to the fourth fiber.

• 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: 20201229
• Report Number: 2124215-2024-56811
• Device Sequence Number: 7535348
• Product Code: GEX
• UDI-Device Identifier: 08714729978619
• UDI-Public: 08714729978619
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 11/22/2024

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 Model Number: 2130-01
• Device Catalogue Number: 2130-01
• Device Lot Number: 0033241196
• 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: 08/23/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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