BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 1241745 · Received November 19, 2008

    Report

    Report Number
    1820334-2008-00655
    Event Type
    Injury
    Date Received
    November 19, 2008
    Date of Event
    January 29, 2008
    Report Date
    November 3, 2008
    Manufacturer
    COOK INC
    Product Code
    DQY
    PMA / PMN Number
    K032869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO ASSIST IN OUR 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. IT IS RECOMMENDED TO NOT EXCEED MAXIMUM INFLATION VOLUME AND THAT WHEN USED TO EXPAND VASCULAR PROSTHESIS, THE BALLOON SHOULD REMAIN WITHIN THE PROSTHESIS AT LEAST 1CM FROM THE PROXIMAL OR DISTAL EDGE OF THE PROSTHESIS. THE APPROPRIATE INDIVIDUALS HAVE BEEN NOTIFIED OF THIS MATTER, AND WE WILL CONTINUE TO MONITOR FOR SIMILAR REPORTS.

    Description of Event or Problem · 1

    IN EARLY 2008, ANOTHER MANUFACTURER'S ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT AND CONTRALATERAL LEG COMPONENT WERE IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THIS EVENT WAS AN EMERGENT CASE. THERE WERE NO COMPLICATIONS IN THE PROCEDURE, BUT THE FINAL ANGIOGRAM REVEALED A TYPE I ENDOLEAK. THE PHYSICIAN ATTEMPTED TO BALLOON WITH A 34 MM COOK CODA BALLOON AND THE ANGIOGRAM REVEALED AN CUTE AORTIC RUPTURE PROXIMAL TO THE EXCLUDER DEVICE, DISTAL TO THE LOWEST RENAL. THE PATIENT COMPLAINED OF BACK PAIN. ANGIOGRAM REVEALED A PERSISTENT TYPE I ENDOLEAK. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED IN THE PATIENT AND RELIEVED THE PATIENT'S BACK PAIN. FSA REPORTED THE AORTIC EXTENDER COMPONENT NEEDED WAS NOT AVAILABLE FOR THE PROCEDURE. FINAL ANGIOGRAM REVEALED CONTRAST IN THE AORTIC CUFF AND TRUNK IPSILATERAL AND NO BLUSH IN THE ANEURYSM SAC. THE PHYSICIAN DECIDED NOT TO INTERVENE. THE PATIENT REMAINED IN STABLE CONDITION AND WAS DISCHARGED ON THE FOLLOWING MONTH.

    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 Required Intervention