BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPTIVATOR II

    MDR report key: 23548874 · Received November 13, 2025

    Report

    Report Number
    3005099803-2025-05983
    Event Type
    Injury
    Date Received
    November 13, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FDI
    PMA / PMN Number
    K202478
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE UPN AND LOT NUMBER OF THE SUSPECT DEVICE. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK H6: IMDRF PATIENT CODE E0506 CAPTURES THE REPORTABLE EVENT OF BLEEDING. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PERFORATION. IMDRF IMPACT CODE F2202 CAPTURES THE REPORTABLE EVENT OF ENDOSCOPIC PROCEDURE.

    Description of Event or Problem · 0

    BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING A CAPTIVATOR - SNARES THROUGH THE ARTICLE, CLIPPING CLOSURE LENGTH IS A CRUCIAL FACTOR FOR DELAYED BLEEDING AFTER ENDOSCOPIC PAPILLECTOMY: A RETROSPECTIVE MULTICENTER COHORT STUDY, BY YUKI FUJII, ET AL. PER THE ARTICLE, BETWEEN NOVEMBER 2003 AND OCTOBER 2023, 130 PATIENTS WHO UNDERWENT ENDOSCOPIC PAPILLECTOMY (EP) WERE RETROSPECTIVELY ANALYZED. OUT OF 130 PATIENTS, PREVENTIVE CLIPPING CLOSURE WAS PERFORMED IN 83 PATIENTS. THERE WERE 37 THAT EXPERIENCED POST-ENDOSCOPIC PAPILLECTOMY (EP) BLEEDING EVENTS, DIVIDED INTO INTRAOPERATIVE AND DELAYED BLEEDING. THE DELAYED BLEEDING OCCURRED IN 22 PATIENTS, WITH MODERATE TO SEVERE CASES PREDOMINATING. MOST OF THE DELAYED BLEEDING OCCURRED MORE OFTEN WITHOUT CLIPPING THAN WITH CLIPPING. ALL BLEEDING CASES WERE SUCCESSFULLY MANAGED WITH ENDOSCOPIC HEMOSTASIS, SOME REQUIRED BLOOD TRANSFUSIONS. ALL EVENTS WERE NON-FATAL, AND NO PATIENTS REQUIRED SURGICAL INTERVENTION OR INTENSIVE CARE ADMISSION. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249203 CAPTIVATOR II SNARE, FLEXIBLE FDI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown