BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 1141074 · Received August 29, 2008

    Report

    Report Number
    1820334-2008-00519
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 19, 2008
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K032869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EACH CODA DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE WARNINGS, PRECAUTIONS, AND THE CORRECT INFLATION PROCEDURE. THE IFU SPECIFICALLY STATES DO NOT EXCEED MAXIMUM INFLATION VOLUME AND THAT WHEN USED TO EXPAND VASCULAR PROSTHESIS, THE BALLOON SHOULD REMAIN WITHIN THE PROSTHESIS AT LEAST 1 CM FROM THE PROXIMAL OR DISTAL EDGE. NO PRODUCT WAS RECEIVED TO ASSIST IN THIS INVESTIGATION. AN INTERNAL CLINICAL REVIEW INDICATED THE EVENT WAS MOST LIKELY DUE TO THE USER ERROR. HOWEVER, THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    IN 2008, A MALE UNDERWENT ENDOVASCULAR REPAIR WITH ANOTHER MANUFACTURER'S ENDOPROSTHESIS. COMPLETION ANGIOGRAM REVEALED AN UNSPECIFIED PRIMAL TYPE I ENDOLEAK. THE PHYSICIAN RE-BALLOONED THE DEVICES USING A 32MM COOK CODA BALLOON CATHETER. AN AORTIC TEAR WAS NOTED IMMEDIATELY AFTER BALLOONING. AN AORTIC EXTENDER WAS PLACED BUT THIS DID NOT RESOLVE THE TEAR, SO ANOTHER MANUFACTURER'S BALLOON-EXPANDABLE STENT WAS PLACED WHICH RESOLVED THE TEAR. A POSTOPERATIVE CT REVEALED A PSEUDOANEURYSM NEAR THE RENAL ARTERIES. THE PATIENT IS CURRENTLY DOING WELL.

    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 76 YR Required Intervention