BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAVVY BALLOON CATHETER 120 CM LONG BALLOON 6 MM WIDE X 2 CM LONG

    MDR report key: 1980181 · Received February 2, 2011

    Report

    Report Number
    MW5019259
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 26, 2011
    Manufacturer
    CORDIS
    Product Code
    LIT
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN IR FOR CELIAC ARTERY EVALUATION WITH ANGIOGRAPHY AND ANGIOPLASTY WHICH WAS COMPLICATED WHEN BALLOON TRAPPED AND RUPTURED AT LEFT BRACHIAL ARTERY ACCESS POINT. TRANSPORTED TO THE OPERATING ROOM FOR REMOVAL AND REPAIR OF ARTERY WITH A BOVINE PERICARDIAL PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY BALLOON CATHETER 120 CM LONG BALLOON 6 MM WIDE X 2 CM LONG LIT CORDIS 15283800

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR