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

Model Number	M00516010
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6 device code: 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 brush was used during a robotic bronchoscopy procedure performed on (b)(6) 2024.Before the device could be used, the brush would not deploy.The yellow tubing was broken off.The procedure was reported to be completed with another of the same device.There were no patient complications reported due to this event.
Additional Manufacturer Narrative
Block h6 device code: imdrf device code a0501 captures the reportable event of working length detached.Block h11: investigation results, the returned celebrity brush was received for analysis.Visual examination revealed that the working length yellow tubing is detached from the handle which doesn't allow the brush extension.The reported event was confirmed.Based on the available information, the investigation findings were most likely a result of the manipulation of the device once it was taken out of the pouch.If it was grabbed by the yellow tubing, it could have gotten damaged internally and when deployed during the preparation it wouldn't deploy normally.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a celebrity brush was used during a robotic bronchoscopy procedure performed on (b)(6) 2024.Before the device could be used, the brush would not deploy.The yellow tubing was broken off.The procedure was reported to be completed with another of the same device.There were no patient complications reported due to 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20031739
• Report Number: 3005099803-2024-04048
• Device Sequence Number: 6414233
• Product Code: BTG
• UDI-Device Identifier: 08714729746249
• UDI-Public: 08714729746249
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: 05/07/2026
• Device Model Number: M00516010
• Device Catalogue Number: 1601S
• Device Lot Number: 0033978753
• 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: 07/23/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2024
• 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