BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXALT MODEL D SINGLE USE DUODENOSCOPE - CLINICAL

    MDR report key: 24626710 · Received March 18, 2026

    Report

    Report Number
    3005099803-2026-00999
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    June 16, 2025
    Report Date
    April 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDT
    PMA / PMN Number
    K193202
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF CODE: E1021 CAPTURES THE REPORTABLE EVENT OF PANCREATITIS. IMDRF CODE: F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC DIAGNOSTIC PROCEDURE. IMDRF CODE: F08 CAPTURES THE REPORTABLE EVENT OF HOSPITALIZATION OR PROLONGED HOSPITALIZATION. BLOCK B3: DATE OF EVENT REPRESENTS THE ARTICLE ONLINE PUBLISHING DATE. BLOCK D4, H4: DETAILED MODEL NUMBER AND LOT NUMBER WERE NOT PROVIDED TO BSC. GOOD FAITH EFFORTS WERE COMPLETED TO OBTAIN THIS INFORMATION; HOWEVER FURTHER INFORMATION HAS NOT BEEN RECEIVED TO DATE. BECAUSE THE PRODUCT INFORMATION IS CURRENTLY UNKNOWN, NO UDI AND OTHER PRODUCT SPECIFIC INFORMATION IS AVAILABLE. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK G2: LITERATURE SOURCE. JOURNAL ARTICLE: IYIAD ALABDUL RAZZAK, ET AL. "EFFICACY AND SAFETY OF SINGLE USE DUODENOSCOPES IN COMPARISON TO REUSABLE DUODENOSCOPES FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A SINGLE CENTER EXPERIENCE", WORLD JOURNAL OF GASTROINTESTINAL ENDOSCOPY, 2025; DOI: 10.4253/WJGE.V17.I6.105298.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING EXALT MODEL D SINGLE-USE DUODENOSCOPE THROUGH THE ARTICLE TITLED: EFFICACY AND SAFETY OF SINGLE USE DUODENOSCOPES IN COMPARISON TO REUSABLE DUODENOSCOPES FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY: A SINGLE CENTER EXPERIENCE BY IYIAD ALABDUL RAZZAK, ET AL. PER THE ARTICLE, BETWEEN 2020 AND 2023, 133 PATIENTS UNDERGOING ERCPS USING EITHER EXALT MODEL D OR A REUSABLE SCOPE WERE ENROLLED. 53 PATIENTS WERE ENROLLED IN THE EXALT MODEL D GROUP. SUCCESS RATES AND ADVERSE EVENTS ASSOCIATED WITH BOTH SCOPE TYPES WERE COMPARED. ADVERSE EVENTS ASSOCIATED WITH USE OF EXALT MODEL D INCLUDE 3 OCCURRENCES OF POST ERCP PANCREATITIS, 2 OCCURRENCES OF MINOR BLEEDING POST SPHINCTEROTOMY, AND 1 OCCURRENCE OF GASTRIC ULCER WITH MELENA AND ANEMIA. THE ULCER WAS TREATED WITH CLIPS. READMISSION OCCURRED IN TWO CASES, ONCE FOR POST SPHINCTEROTOMY BLEEDING AND ONCE FOR POST ERCP PANCREATITIS. ONE PATIENT DEVELOPED A PERFORATION WHICH WAS ATTRIBUTED TO BALLOON DILATION BY GASTROSCOPE TO OVERCOME GASTRIC OUTLET OBSTRUCTION. ALL CASES OF POST ERCP PANCREATITIS WERE CLASSIFIED AS MILD, NONE OF THE CASES REQUIRED INTENSIVE CARE UNIT ADMISSION, AND ALL WERE MANAGED CONSERVATIVELY. BLEEDING EVENTS WERE ALSO CLASSIFIED AS MILD AS THEY WERE ENDOSCOPICALLY CONTROLLED WITH NO NEED FOR BLOOD TRANSFUSIONS OR FURTHER INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687075 EXALT MODEL D SINGLE USE DUODENOSCOPE - CLINICAL DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID FDT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown