BEUDAMED
    FDA Adverse Event Other Summary report: N

    EAGLE EYE CATHETER

    MDR report key: 1001462 · Received February 20, 2008

    Report

    Report Number
    2939520-2008-00004
    Event Type
    Other
    Date Received
    February 20, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 12, 2008
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE CATHETER, A TEAM CONSISTING OF RESEARCH AND DEVELOPMENT, MFG ENGINEERING, QUALITY, AND REGULATORY MET TO EVALUATE THE RETURNED CATHETER. THE DISTAL END OF THE SHAFT WAS SEPARATED JUST DISTAL OF THE EXIT PORT SKIVE. THE INNER LUMEN, DISTAL SHAFT AND MICROCABLE WERE SEPARATED SUCH THAT THERE WERE TWO COMPLETELY SEPARATED PIECES OF THE CATHETER. THE CATHETER WAS 'ACCORDIONED' PROXIMAL TO THE SCANNER. ALTHOUGH THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO AN INJURY, A REPORT OF A CATHETER TIP DETACHMENT CAN HAVE SERIOUS CONSEQUENCE; THEREFORE, THIS REPORT IS BEING SUBMITTED AS A NOTIFICATION.

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO LOAD THE CATHETER ON THE 0.014 WIRE, THE CATHETER BECAME VERY DIFFICULT TO THREAD. THE PHYSICIAN ATTEMPTED TO PULL IT OFF THE WIRE WITH GREAT FORCE. THE CATHETER CAME APART INTO TWO PIECES WITH PART OF THE WIRE REMAINING IN THE CATHETER. THE CATHETER NEVER ENTERED THE PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLE EYE CATHETER IVUS CATHETER DQO VOLCANO CORPORATION 85900 00208750

    Patients

    Seq Age Sex Outcome Treatment
    1