MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXCELON; BRONCHOSCOPE (FLEXIBLE OR RIGID)

Model Number	6412
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter phone number is (b)(6).Block h6: imdrf device code a0501 captures the reportable event of needle detached.
Event or Problem Description
It was reported to boston scientific corporation that a excelon tbna needle was used in the lungs during a pulmo procedure performed on (b)(6) 2025.During the procedure, the needle was removed from the patient after a second puncture.When the needle was extended to release the second sample, the needle fell out of the sheath.Another excelon was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter phone number is (b)(6).Block h6: imdrf device code a0501 captures the reportable event of needle detached.Block h11: the returned excelon tbna needle was analyzed, and no visual damages were found.However, during functional test, the needle was not able to retract.Under microscope inspection, the needle was observed detached from the working length.The customer provided some images where it can be observed the label information of the device, and the needle detached from the working length.The reported event of needle detached was confirmed.Based on all available information, it is most likely that procedural factors such as handling of the device and the technique used by the physician (force applied) could have resulted in the damages encountered in the device, making the needle to detached during the procedure.This conclusion is acceptable because the adverse event occurred during the procedure and the device had no influence on event.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a excelon tbna needle was used in the lungs during a pulmo procedure performed on (b)(6) 2025.During the procedure, the needle was removed from the patient after a second puncture.When the needle was extended to release the second sample, the needle fell out of the sheath.Another excelon was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: EXCELON
• Common Device Name: BRONCHOSCOPE (FLEXIBLE OR RIGID)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21796665
• Report Number: 3005099803-2025-01470
• Device Sequence Number: 8230705
• Product Code: EOQ
• UDI-Device Identifier: 08714729456476
• UDI-Public: (01)08714729456476(17)260712(10)32005173
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K040018
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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 Expiration Date: 07/12/2026
• Device Model Number: 6412
• Device Catalogue Number: 6412
• Device Lot Number: 0032005173
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 04/08/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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