BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEBRITY

    MDR report key: 21447056 · Received February 24, 2025

    Report

    Report Number
    3005099803-2025-00399
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    April 1, 2020
    Report Date
    February 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    BTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE STUDY STARTED IN THE LITERATURE ARTICLE. BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER AND UPN WERE NOT REPORTED. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: KARSENTI D, PRIVAT J, CHARISSOUX A, PERROT B, LEBLANC S, CHAPUT U, BOYTCHEV I, LEVY J, SCHAEFER M, BOURGAUX JF, VALATS JC, CORON E, MORENO-GARCIA M, VANBIERVLIET G, RAHMI G, ROBLES EP, WALLENHORST T. MULTICENTER RANDOMIZED TRIAL COMPARING DIAGNOSTIC SENSITIVITY AND CELLULAR ABUNDANCE WITH AGGRESSIVE VERSUS STANDARD BILIARY BRUSHING FOR BILE DUCT STENOSIS WITHOUT MASS SYNDROME. ENDOSCOPY. 2023 SEP;55(9):796-803. DOI: 10.1055/A-2041-7687.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING CELEBRITY CYTOLOGY BRUSH THROUGH THE ARTICLE "MULTICENTER RANDOMIZED TRIAL COMPARING DIAGNOSTIC SENSITIVITY AND CELLULAR ABUNDANCE WITH AGGRESSIVE VERSUS STANDARD BILIARY BRUSHING FOR BILE DUCT STENOSIS WITHOUT MASS SYNDROME" BY DAVID KARSENTI ET AL. PER THE ARTICLE, BETWEEN APRIL 1, 2020, AND OCTOBER 2021, 51 PATIENTS UNDERWENT ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURES FOR BILE DUCT STENOSIS. THREE PATIENTS EXPERIENCED GASTROINTESTINAL BLEEDING, REQUIRING BLOOD TRANSFUSION OF FOUR UNITS OF BLOOD IN ADDITION TO AN ENDOSCOPIC HEMOSTASIS PROCEDURE IN ONE PATIENT WITH SPHINCTEROTOMY. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559041 CELLEBRITY BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) BTG BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention