BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 1053353 · Received May 28, 2008

    Report

    Report Number
    1820334-2008-00296
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    November 27, 2007
    Report Date
    April 29, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQY
    PMA / PMN Number
    K032869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A PT WAS UNDERGOING AAA REPAIR IN 2007 WITH ANOTHER MANUFACTURER'S ENDOPROSTHESIS. THE PHYSICIAN USED TWO WIRE GUIDES PRIOR TO PLACING THE ENDOVASCULAR DEVICES TO STRAIGHTEN THE VESSELS. WHILE STRAIGHTENING THE VESSELS, THE VENA CAVA WAS PUNCTURED. THE PHYSICIAN THEN WENT ON TO PLACE THE ENDOVASCULAR DEVICES AND WHEN USING THE CODA BALLOON CATHETER TO EXPAND THE AAA DEVICES, THE AORTA RUPTURED. ON THE NEXT DAY, THE PHYSICIAN EXPLANTED THREE OF THE FOUR ENDOPROSTHESIS AND AFTER AN EXTENDED HOSPITAL STAY, THE PATIENT IS REPORTED TO HAVE RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODA BALLOON CATHETER DQY BALLOON CATHETER DQY COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R