BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRE BALLOON DILATOR CATHETER

    MDR report key: 22776899 · Received August 11, 2025

    Report

    Report Number
    MW5174360
    Event Type
    Injury
    Date Received
    August 11, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BALLOON DILATOR ONCE DEFLATED GOT STUCK IN SCOPE CHANNEL.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 14 AUG 2025 FOR MW5174360 TO CORRECT PROCODE. PROCODE: KNQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240140 CRE BALLOON DILATOR CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Required Intervention