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

Model Number	M00516150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reported event of wire within the catheter broke near the brush portion.
Event or Problem Description
It was reported to boston scientific corporation that a cellebrity pulmonary cytology brush was used during a bronchoscopy procedure performed on (b)(6) 2024.During the procedure, the wire broke within the catheter near the brush portion.The brush did not completely detach.It is unknown how the procedure was completed.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reported event of wire within the catheter broke near the brush portion.Block h11: the returned cellebrity biopsy brush was analyzed.Visual and microscope inspection observed the working length was severely kinked at several sections.The catheter was torn near to the handle, the wire was kinked but not broken.The reported event of wire break was not confirmed and will be classified as no problem detected.The problem found is most likely has to do with the technique applied to the device when it was being used.Excessive force must have been used when extending and retracting the brush in order to kink the working length.The same motion used by the physician when extending and retracting the brush probably kinked and tore the working length.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 cellebrity pulmonary cytology brush was used during a bronchoscopy procedure performed on (b)(6) 2024.During the procedure, the wire broke within the catheter near the brush portion.The brush did not completely detach.It is unknown how the procedure was completed.No patient complications were 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20268699
• Report Number: 3005099803-2024-04587
• Device Sequence Number: 15257005
• Product Code: BTG
• UDI-Device Identifier: 08714729746331
• UDI-Public: 08714729746331
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 11/14/2024

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: 10/19/2025
• Device Model Number: M00516150
• Device Catalogue Number: 1615S
• Device Lot Number: 0032680449
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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