MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CELLEBRITY; BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID)

Model Number	M00516001
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	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of brush detachment.
Event or Problem Description
Note: this report pertains to one of two pulmonary cytology brushes used in the same procedure.It was reported to boston scientific corporation that a pulmonary cytology brush was to be used during a pulmonary procedure performed on (b)(6) 2025.During the procedure, a cytology brush was operated, and it was observed that there was no brush attached to the metal tip.Another brush was opened from the same lot, which also did not have a brush attached on the metal tip.The procedure was completed using another pulmonary cytology brush.There were no patient complications reported as a result of this event.

• Brand Name: CELLEBRITY
• Common Device Name: BRUSH, BIOPSY, BRONCHOSCOPE (NON-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: 21501803
• Report Number: 3005099803-2025-00620
• Device Sequence Number: 8020920
• Product Code: BTG
• UDI-Device Identifier: 08714729138983
• UDI-Public: 08714729138983
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K780872
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2025

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 Expiration Date: 09/04/2025
• Device Model Number: M00516001
• Device Catalogue Number: 1600
• Device Lot Number: 0032361580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/03/2025
• Date Device Manufactured: 09/05/2023
• 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: Prefer Not To Disclose