BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIONS PV 8.2 IVUS CATHETER

    MDR report key: 597435 · Received April 25, 2005

    Report

    Report Number
    2939520-2005-00002
    Event Type
    Other
    Date Received
    April 25, 2005
    Date of Event
    March 21, 2005
    Report Date
    April 25, 2005
    Manufacturer
    VOLCANO CORP.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE CATHETER BROKE OFF AS THE USER WAS PULLING THE CATHETER OUT OF THE SHEATH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other