BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIONS PV 8.2 IVUS CATHETER

    MDR report key: 598659 · Received April 29, 2005

    Report

    Report Number
    2939520-2005-00003
    Event Type
    Other
    Date Received
    April 29, 2005
    Date of Event
    April 4, 2005
    Report Date
    April 4, 2005
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER IMAGING THEY ATTEMPTED TO PULL THE CATHETER OUT OF THE BODY WHEN THEY ENCOUNTERED SOME RESISTANCE. AS HE BEGAN TO WORK TO GET IT OUT OF THE 16F SHEATH, THE TIP CAME OFF. THE DISTAL TIP WAS RETREIVED FROM THE PT WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV 8.2 IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER ITX VOLCANO CORPORATION * V31994

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other