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); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).: device code a0501 captures the reportable event of brush detachment.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) stone removal procedure performed on (b)(6) 2024.During preparation, when the package was opened, it was found that there were kinked marks on the shaft and the brush tip had detached.Another rx cytology brush was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition following procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: device code a0501 captures the reportable event of brush detachment.Block h11: the returned rx cytology brush was analyzed, and a product analysis observed several kinks throughout the working length.The brush was found not detached; however, it was not able to extend since the wire from the working length is detached from the cannula.The reported brush detachment was not confirmed.The complaint information reports that the device was damaged prior to procedure; however, it returned with damages that suggest that the device was used during a procedure.Based on all available information, it is most likely due to the physician's technique at the time of extending and retracting the brush which due to friction and possible tortuosity of the procedure could have caused the detachment.Therefore, the most probable root cause of the investigation findings handle detached/separated and working length bent/kinked is adverse event related to procedure.The brush was not detached as reported; however, it wasn't able to be extended from the working length since the wire from the handle cannula was detached.Therefore, the reported event of brush detachment was addressed as no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) stone removal procedure performed on (b)(6) 2024.During preparation, when the package was opened, it was found that there were kinked marks on the shaft and the brush tip had detached.Another rx cytology brush was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition following procedure was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21126911
• Report Number: 3005099803-2025-00016
• Device Sequence Number: 7677454
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K930348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 03/12/2025

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: 02/12/2026
• Device Model Number: M00545000
• Device Catalogue Number: M00545000
• Device Lot Number: 0033411974
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2024
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 58 KG