BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE¿ PRO

    MDR report key: 22456334 · Received July 9, 2025

    Report

    Report Number
    22456334
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CRE PRO WIREGUIDED BALLOON 18-20MM SIZE LOT#36202008 EXP 2028-03-31 GTIN (B)(4) HAD A LEAK AS IT WAS TRYING TO BE INFLATED IN THE PT ESOPHAGUS. NO INJURY, BUT ADDITIONAL TIME REQUIRED WITH SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118424 CRE¿ PRO CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORPORATION M00558710 36202008

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female