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

Model Number	2130-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 date of event: the exact event date is unknown.This is for the same event as manufacturer reports 2124215-2024-47971.
Event or Problem Description
It was reported that during the procedure, the fiber tip was broken after a short amount of time lasing.The procedure was completed with another fiber and no patient complications reported.This is the second the two complaints.
Additional Manufacturer Narrative
B3 date of event: the exact event date is unknown.Upon receipt at our quality assurance laboratory, the fiber underwent a thorough analysis.The fiber was received in one piece; there were no anomalies in the fiber body.Visual inspection found that the fiber tip was broken.Therefore, the reported event was confirmed.Additionally, the aim beam was bright and distorted due to tip break.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.The instructions for use (ifu) instructs that care should be exercised with the glass tip to avoid severe impact or side stresses that may fracture the tip.This is for the same event as manufacturer reports 2124215-2024-47971.
Event or Problem Description
It was reported that during the procedure, the fiber tip was broken after a short amount of time lasing.The procedure was completed with another fiber and no patient complications reported.This is the second the two complaints.

• 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: 19988661
• Report Number: 2124215-2024-48592
• Device Sequence Number: 18278704
• Product Code: GEX
• UDI-Device Identifier: 08714729978701
• UDI-Public: 08714729978701
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,Followup
• Report Date (Section B): 09/20/2024

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: 05/15/2026
• Device Model Number: 2130-02
• Device Catalogue Number: 2130-02
• Device Lot Number: 0031624212
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2023
• 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