BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 1962664 · Received January 10, 2011

    Report

    Report Number
    1820334-2011-00013
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 13, 2010
    Manufacturer
    COOK INC
    Product Code
    DQY
    PMA / PMN Number
    K032869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. EACH CODA BALLOON IS SHIPPED WITH AN INSTRUCTIONS FOR USE (IFU) LISTING WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. SPECIFICALLY, IT WARNS THAT OVER INFLATION MAY RESULT IN DAMAGE AND/OR VESSEL RUPTURE. IT ALSO STATES TO ENSURE THE MARKERS ON THE BALLOON ARE INSIDE THE VASCULAR PROSTHESIS, IF USED IN THE APPLICATION. THE IFU PROVIDES DETAILS CONCERNING BALLOON INFLATION AND THE INFLATION PARAMETERS. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN THE REPORTED RUPTURE. PT ANATOMY (CALCIFICATION, DISEASE, ETC.) AND USER TECHNIQUE LIKELY CONTRIBUTED TO THE REPORTED RUPTURE. INFLATION OUTSIDE OF THE GRAFT MATERIAL MAY INCREASE THE RISK OF VESSEL RUPTURE. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA) AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A PT UNDERWENT AAA REPAIR WITH ANOTHER MFR'S STENTS ON (B)(6) 2010. ACCESS VESSEL WAS NARROW DUE TO CALCIFICATION. FINAL ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK AFTER ANOTHER MFR'S STENTS WERE PLACED. BALLOONING WITH THE CODA BALLOON CATHETER WAS PERFORMED AND ANGIOGRAPHY WAS PERFORMED AGAIN. IT WAS CONFIRMED PROXIMAL NECK WAS RUPTURED. AORTA ABOVE RENAL ARTERY WAS OCCLUDED WITH THE CODA BALLOON CATHETER AND AN ADD'L 26MM STENT WAS PLACED OVER RENAL ARTERY. MOREOVER, ANOTHER 23MM STENT WAS PLACED. ANGIOGRAPHY REVEALED BLEEDING WAS RESOLVED AND IT WAS CONFIRMED VITAL SIGNS WERE STABLE. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC NA F2567998

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention