BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR II

    MDR report key: 23500427 · Received November 7, 2025

    Report

    Report Number
    3005099803-2025-05932
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    January 1, 2021
    Report Date
    November 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K202478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK E1: (INITIAL REPORTER FACILITY NAME) THE REPORTED HEALTH CARE FACILITY IS (B)(6) HOSPITAL. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE. IMDRF IMPACT CODE F2301 CAPTURES THE REPORTABLE EVENT OF ADDITIONAL DEVICE REQUIRED.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A CAPTIVATOR - SNARES THROUGH THE ARTICLE, OUTCOMES OF UNDERWATER ENDOSCOPIC MUCOSAL RESECTION FOR COLORECTAL POLYPS - INSIGHTS FROM WESTERN INDIA, BY SRIDHAR SUNDARAM, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2021 AND JUNE 2023, 159 PATIENTS WITH SESSILE COLORECTAL POLYPS MORE THAN 10 MM IN SIZE WITHOUT ANY FEATURES OF SUB-MUCOSAL INVASION UNDERWENT UEMR (UNDERWATER ENDOSCOPIC MUCOSAL RESECTION). A TOTAL OF 18 ADVERSE EVENTS WERE IDENTIFIED AMONG 261 PROCEDURES. THEY ENCOUNTERED TEN INTRA-PROCEDURAL BLEEDINGS, FOUR DEEP MURAL INJURY (TYPE II DMI), AND FOUR DELAYED BLEEDING (POST-PROCEDURE DAY 5). ALL EVENTS WERE MANAGED ENDOSCOPICALLY WITHOUT SURGICAL INTERVENTION. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182021 CAPTIVATOR II SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention