BEUDAMED
    FDA Adverse Event Death Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 1221464 · Received November 4, 2008

    Report

    Report Number
    1820334-2008-00590
    Event Type
    Death
    Date Received
    November 4, 2008
    Report Date
    October 6, 2008
    Manufacturer
    COOK INC.
    Product Code
    DQY
    PMA / PMN Number
    K032869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION; THEREFORE, WE WERE NOT ABLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THIS DEVICE IS SHIPPED WITH AN "INSTRUCTIONS FOR USE" BOOKLET THAT LISTS THE WARNINGS AND PRECAUTIONS, AND THE CORRECT INFLATION PROCEDURE. ADDITIONALLY, THE BALLOON DIAMETER IS VERIFIED 100% BY OUR QUALITY CONTROL DEPARTMENT PRIOR TO FURTHER SHIPPING. NEVERTHELESS, THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED OF THIS MATTER, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    ANOTHER MANUFACTURER'S AAA ENDOPROSTHESIS WAS DEPLOYED. UPON BALLOONING WITH OUR CODA BALLOON, THE PHYSICIAN BALLOONED 3 TIMES AND THE ANEURYSM RUPTURED - PATIENT EXPIRED ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death