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

Model Number	1615
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	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of working length detached.
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity cytology brush was used in a bronchoscopy procedure performed on (b)(6) 2025.During the procedure, when they pulled the brush out of the scope, the internal wire stayed in the scope and the patient.A photo of the device was provided showing the working length was detached.The brush was removed by pulling the wire sticking out of the scope.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a celebrity cytology brush was used in a bronchoscopy procedure performed on (b)(6) 2025.During the procedure, when they pulled the brush out of the scope the internal wire stayed in the scope and the patient.A photo of the device was provided showing the working length detached.The brush was removed by pulling the wire sticking out of the scope.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.Block h11: the device was not returned for analysis.However, media analysis was performed on the picture provided, and it was observed that the working length was detached and the device is in a plastic bag.Based on all available information, the most probable cause of the reported issue of working length detachment of device or device component cannot be established due to lack of evidence.The product was not returned for analysis to identify any defect with the device.The customer provided a picture where it can be observed the working length detached and the device in a plastic bag; however, without proper evaluation of the device, it remains unknown the most probable causes that contributed to the event.Therefore, the most probable root cause cannot be established.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23125996
• Report Number: 3005099803-2025-04874
• Device Sequence Number: 12610962
• Product Code: BTG
• UDI-Device Identifier: 08714729014003
• UDI-Public: (01)08714729014003(17)270617(10)36773442
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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 Model Number: 1615
• Device Catalogue Number: 1615
• Device Lot Number: 0036773442
• 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: 08/26/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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