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

Model Number	M00545000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Inflammation (1932); Pain (1994); Pancreatitis (4481); Cholangitis (4821)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: estimated date of event is based on the article published date.Block e1: the initial reporter facility name is (b)(6).Block d4, h4: the suspect device lot number and upn were not reported.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf patient code e1109 captures the reportable event of cholangitis.Imdrf patient code e0506 captures the reportable event of gastro-intestinal bleeding.Imdrf patient code e2330 captures the reportable event of post-procedural pain.Imdrf patient code e2326 captures the reportable event of cholecystitis.
Event or Problem Description
Boston scientific became aware of an event involving rx cytology brushes through the article, comparison of two intraductal brush cytology devices for suspected malignant biliary strictures: randomized controlled trial, by myrte gorris, et al.Per the article, between june 2016 and june 2021, rx cytology brushes were used in endoscopic retrograde cholangiopancreatography (ercp) procedures during a randomized controlled trial.Procedure-related adverse events mentioned in the article included pancreatitis, gastro-intestinal bleeding, cholangitis, cholecystitis, and post-procedural pain.Please see the referenced article for full details.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21425843
• Report Number: 3005099803-2025-00553
• Device Sequence Number: 7855160
• 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,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M00545000
• Device Catalogue Number: M00545000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/20/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown