BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELLEBRITY

    MDR report key: 21449735 · Received February 24, 2025

    Report

    Report Number
    3005099803-2025-00561
    Event Type
    Injury
    Date Received
    February 24, 2025
    Date of Event
    February 1, 2025
    Report Date
    February 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    BTG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK E1: INITIAL REPORTER FACILITY NAME: (B)(6). BLOCK H6: IMDRF PATIENT CODE E1002 CAPTURES THE REPORTABLE EVENT OF ABDOMINAL PAIN. IMDRF PATIENT CODE E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF IMPACT CODE F1903 CAPTURES THE REPORTABLE EVENT OF DEVICE EXPLANTATION.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF EVENTS INVOLVING CELLEBRITY CYTOLOGY BRUSH THROUGH THE ARTICLE "DIAGNOSTIC YIELD OF SERIAL PANCREATIC JUICE ASPIRATION CYTOLOGIC EXAMINATION WITH BRUSH CYTOLOGY FOR PANCREATIC DUCTAL STENOSIS" BY TAKAFUMI MIE ET AL. PER THE ARTICLE, SIXTEEN PATIENTS UNDERWENT SURGERY, 15 OF WHICH WERE MALIGNANT AND 1 WAS INTRADUCTAL PAPILLARY MUCINOUS ADENOMA. INTRADUCTAL PAPILLARY MUCINOUS ADENOCARCINOMA WAS PRESENT IN 5 CASES, 3 CASES OF WHICH SHOWED ADENOCARCINOMA IN SPACE WITH BRUSH CYTOLOGY. IN 1 CASE OF NEUROENDOCRINE NEOPLASMS, CARCINOMA CELLS WERE IDENTIFIED IN SPACE WITH BRUSH CYTOLOGY. NO PATIENTS DIED OF AES. POST-ERCP PANCREATITIS WAS OBSERVED IN 4 CASES, ALL WITH MILD CASES, AND ABDOMINAL PAIN IMPROVED QUICKLY AFTER REMOVAL OF ENPD CATHETER IN ALL PATIENTS WITH PEP. HYPERAMYLASEMIA (WITHOUT ABDOMINAL PAIN) OCCURRED IN 11 CASES. IN THIS STUDY, THERE WERE 2 PATIENTS WHO HAD ABDOMINAL PAIN WITH HYPERAMYLASEMIA AFTER REMOVAL OF THE ENPD CATHETER, ALTHOUGH PEP DID NOT OCCUR. ONE PATIENT WAS MILD CASE, AND ANOTHER WAS MODERATE CASE. THERE WAS NO CASE OF BLEEDING AND PERFORATION. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527842 CELLEBRITY BRUSH, BIOPSY, BRONCHOSCOPE (NON-RIGID) BTG BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other