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

Model Number	M00516011
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	12/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity cytology brush was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2024.During the procedure, the sheath pulled off the wire and brush.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of working length detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of working length detached.Block h2 (additional information): block b5 has been updated based on the additional information received on january 21, 2025.
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity cytology brush was used in the lungs during a bronchoscopy procedure performed on (b)(6) 2024.During the procedure, the sheath pulled off the wire and brush.There were no patient complications as a result of this event.***additional information received on january 21, 2025*** the procedure was completed with another same device.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21266145
• Report Number: 3005099803-2025-00135
• Device Sequence Number: 18294218
• Product Code: BTG
• UDI-Device Identifier: 08714729138990
• UDI-Public: 08714729138990
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 09/11/2026
• Device Model Number: M00516011
• Device Catalogue Number: 1601
• Device Lot Number: 0034826047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/12/2025
• Date Device Manufactured: 09/11/2024
• 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