inforMED
InjuryFDX

RX CYTOLOGY BRUSH

Received Feb 20, 2025 · Event occurred Feb 27, 2023

Report 3005099803-2025-00553 · MDR key 21425843

Device

Generic name

Endoscopic Cytology Brush

Model number

M00545000

Catalog number

M00545000

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Hemorrhage/Blood Loss/Bleeding
  • Inflammation
  • Pain
  • Pancreatitis
  • Cholangitis
  • Hemorrhage/Blood Loss/Bleeding
  • Inflammation
  • Pain
  • Pancreatitis
  • Cholangitis

Narrative

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.

Description of Event or Problem

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.