BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION

    MDR report key: 1446975 · Received May 26, 2009

    Report

    Report Number
    2939520-2009-00017
    Event Type
    Malfunction
    Date Received
    May 26, 2009
    Date of Event
    April 21, 2009
    Report Date
    May 27, 2009
    Manufacturer
    VOLCANO CORP
    Product Code
    DQO
    PMA / PMN Number
    K080891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE DEVICE WAS PERFORMED TO IDENTIFY CATHETER AND SHAFT DAMAGES SUCH AS BENDS, DENTS, KINKS, CUTS, SCRAPES, CRACKS, DISCOLORATION OR CORROSION. THE CATHETER MUST BE FREE OF ANY MAJOR PHYSICAL DAMAGE BEFORE IT CAN BE ELECTRONICALLY TESTED. DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE DEVICE WAS RECEIVED IN TWO PIECES WITH SEPARATION OCCURRING AT THE BUTT JOINT APPROXIMATELY 239.5 MM FROM DISTAL TIP. THE MONORAIL SECTION WAS DAMAGED/TORN WITH FEATHERED EDGES INDICATING THE CATHETER WAS PULLED. IT APPEARS THAT DEVICE EXPERIENCED A LOAD >5N. NO FUNCTIONAL TESTING OF THE DEVICE WAS PERFORMED. NO MANUFACTURING DEFECTS NOTED. ALTHOUGH THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS INCIDENT, IF THE EVENT WERE TO REOCCUR, THERE COULD BE A POTENTIAL FOR INJURY. THIS REPORT IS BEING SENT AS A NOTIFICATION.

    Description of Event or Problem · 1

    THE CLEAR TUBE PORTION OF THE CATHETER WAS SEPARATED FROM THE REST OF REVOLUTION CATHETER, LEAVING THE CLEAR TUBE WITHIN THE GUIDE CATHETER IN THE ARTERY. THE SEPARATED TUBE WAS TAKEN OUT OF THE PATIENT BODY WITH THE GUIDE CATHETER AND NO PATIENT INJURY OCCURRED. THE PROCEDURE CONTINUED WITH AN EAGLE EYE GOLD CATHETER WHICH FUNCTIONED AS INTENDED THROUGH THE END OF PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION INTRAVASCULAR ULTRASOUND CATHETER DQO VOLCANO CORP 89000 035 02899

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other