COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM

Additional Manufacturer Narrative

BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER AND UPN WERE NOT REPORTED. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL; REPORTED HERE AS THE ADDRESS EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK G2: LITERATURE SOURCE: MINGXING XIA, "DIAGNOSTIC EFFICACY OF A NOVEL ROTATING BRUSH FOR ENDOSCOPIC SAMPLING OF MALIGNANT BILIARY STRICTURES:A MULTICENTER PROSPECTIVE STUDY" DEPARTMENT OF GASTROENTEROLOGY AND ENDOSCOPY, THE THIRD AFFILIATED HOSPITAL OF NAVAL MEDICAL UNIVERSITY, SHANGHAI, CHINA, HTTPS://DOI.ORG/10.5946/CE.2022.213. BLOCK H6: IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF A PANCREATITIS. IMDRF PATIENT CODE E2326 CAPTURES THE REPORTABLE EVENT OF CHOLECYSTITIS. IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF POST-PROCEDURAL BLEEDING. IMDRF PATIENT CODE E1109 CAPTURES THE REPORTABLE EVENT OF CHOLANGITIS. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY/ILLNESS/IMPAIRMENT.

Description of Event or Problem

BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING PULMONARY CYTOLOGY BRUSHES THROUGH THE ARTICLE "DIAGNOSTIC EFFICACY OF A NOVEL ROTATING BRUSH FOR ENDOSCOPIC SAMPLING OF MALIGNANT BILIARY STRICTURES: A MULTICENTER PROSPECTIVE STUDY" BY MINGXING XIA ET AL. PER THE ARTICLE, BETWEEN JUNE 15, 2021, AND APRIL 6, 2023, A STUDY OF 268 PATIENTS SUSPECTED OF MALIGNANT BILIARY STRICTURES UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY TO OBTAIN BRUSHINGS OF BILIARY STRICTURE FOR CYTOLOGIC EVALUATION. TWO TYPES OF BRUSHES WERE USED: RX CYTOLOGY BRUSH, AND NON-BOSTON SCIENTIFIC DEVICE. THE FOLLOWING OCCURRED WITH THE STUDY OF PATIENTS: PROCEDURAL BLEEDING, CHOLANGITIS, CHOLECYSTITIS, AND PANCREATITIS. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.