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 Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation finding of brush detached/separated.Block h11: the returned rx cytology brush was analyzed, and the product analysis found the device was returned without the brush.The orange ring was detached from the cannula and the cannula was kinked.The reported event brush bent was not confirmed.Based on available information, the investigation findings of orange ring from the cannula was kinked and the ring from the handle detached most likely happened due to the physician's technique at the time of extending and retracting the brush.Friction and possible tortuosity of the procedure could have cause the detachment.The brush was not return; therefore, it is most likely that it was manually removed in order to obtain the samples from the procedure.The most probable cause for brush bent/kinked could not be established since the brush was not return for analysis.The most probable cause for the investigation findings is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an rx cytology brush was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with brush procedure performed on (b)(6) 2025.During procedure, at the 4th time inserting the brush, it was more difficult and there was resistance noted.On the 5th time, the metal pin bent, and the brush could no longer fit into the sheath.The brush was sent for pathology.There were no patient complications as a result of this event.This event has been deemed a reportable event based on the investigation finding of brush detached.

• 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: 21562495
• Report Number: 3005099803-2025-00879
• Device Sequence Number: 4373624
• Product Code: FDX
• UDI-Device Identifier: 08714729268628
• UDI-Public: 08714729268628
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/10/2025

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: 07/22/2026
• Device Model Number: M00545000
• Device Catalogue Number: M00545000
• Device Lot Number: 0034478411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2024
• 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