BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAVVY

    MDR report key: 2850109 · Received October 12, 2012

    Report

    Report Number
    2850109
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 12, 2012
    Manufacturer
    CORDIS (A JOHNSON & JOHNSON COMPANY)
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A SAVVY PTA (PERCUTANEOUS TRANSLUMINAL ANGIOGRAPHIC) DILATATION CATHETER (6.0MM X 6CM) MANUFACTURED BY CORDIS WAS PREPPED AND PLACED INTO THE PATIENT THROUGH A SHEATH. IT WAS APPROPRIATELY INFLATED WITH AN INFLATION DEVICE. FOR THIS BALLOON, THE NOMINAL PRESSURE RATE IS 6 ATM AND THE BURST PRESSURE RATE IS 10 ATM. HOWEVER, THE BALLOON RUPTURED AT 5 ATM. A SECOND SAVVY 6.0MM X 6CM WAS PROPERLY PREPPED, INSERTED AND INFLATED. IT TOO RUPTURED, THIS TIME AT 8 ATM. THE CATHETERS WERE FROM THE SAME LOT NUMBER. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAVVY PTA DILATION CATHETER LIT CORDIS (A JOHNSON & JOHNSON COMPANY) * 15536462
    2 SAVVY PTA DILATION CATHETER LIT CORDIS (A JOHNSON & JOHNSON COMPANY) * 15536462

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR