BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION QUATTRO EXTRACTION BALLOON

    MDR report key: 19087306 · Received April 10, 2024

    Report

    Report Number
    MW5153699
    Event Type
    Injury
    Date Received
    April 10, 2024
    Date of Event
    March 17, 2024
    Report Date
    March 22, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC.
    Product Code
    GCA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) FOR COMMON BILE DUCT STONES. COOK FUSION QUATTRO EXTRACTION BALLOON X 2 USED FOR STONE SWEEP AND UPON INFLATION BOTH BALLOONS RUPTURED. A THIRD BALLOON WAS UTILIZED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS. NO PATIENT HARM REPORTED. COOK FUSION QUATTRO EXTRACTION BALLOON: 8.5/10/12/15 MM, REF: FS-QEB-B, LOT#: W4734032, EXP: 06/06/2024. REFERENCE REPORT: MW5153698.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779451 FUSION QUATTRO EXTRACTION BALLOON BILIARY CATHETER FOR STONE REMOVAL THAT MAY ALSO ALLOW FOR IRRIGATION AND CONTRA GCA WILSON-COOK MEDICAL INC. FS-QEB-B W4734032

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention