MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RX CYTOLOGY BRUSH; ENDOSCOPIC CYTOLOGY BRUSH

Model Number	M00545000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of brush tip fractured.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a cytological brush detection of tumors procedure on (b)(6) 2025.During the procedure, the brush tip was fractured and could not be used normally.The procedure was completed using another rx cytology brush.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h2: block b5 has been updated based on the additional information received on november 04, 2025.Block h6: imdrf device code a0501 captures the reportable event of brush tip fractured.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a cytological brush detection of tumors procedure on september 25, 2025.During the procedure, the brush tip was fractured and could not be used normally.The procedure was completed using another rx cytology brush.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information was received on november 04, 2025*** the brush tip was fractured into two separate parts.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during a cytological brush detection of tumors procedure on (b)(6) 2025.During the procedure, the brush tip was fractured and could not be used normally.The procedure was completed using another rx cytology brush.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information was received on november 04, 2025*** the brush tip was fractured into two separate parts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of brush tip fractured.Block h11: investigation results the returned rx cytology brush was received for analysis.A visual examination revealed damage along the working length, with multiple kinks observed in several areas, including kinking of the wire.Due to this damage, extension of the brush could not be performed during functional testing.The distal brush end was observed to be intact, with no evidence of detachment or damage.The reported event could not be confirmed.Based on the available information, the observed damage is most likely attributable to procedural factors, such as device handling and the technique used by the physician, including the application of force during use.A review and analysis of all available information indicate that the most probable root cause for the damage observed during analysis is adverse event related to procedure.The reported event of brush detachment is classified as no problem detected, as the brush was not detached or damaged.

• Brand Name: RX CYTOLOGY BRUSH
• Common Device Name: ENDOSCOPIC CYTOLOGY BRUSH
• 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: 23337315
• Report Number: 3005099803-2025-05095
• Device Sequence Number: 12714539
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: (01)08714729268628(17)270116(10)35645871
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K930348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/22/2025

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: M00545000
• Device Catalogue Number: M00545000
• Device Lot Number: 0035645871
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 11/27/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/25/2025; 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 57 KG