BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISIONS PV 8.2 IVUS CATHETER

    MDR report key: 698197 · Received October 5, 2005

    Report

    Report Number
    2939520-2005-00004
    Event Type
    Other
    Date Received
    October 5, 2005
    Date of Event
    September 14, 2005
    Report Date
    October 5, 2005
    Manufacturer
    VOLCANO CORP.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TIP OF CATHETER BROKE OFF WHILE CATHETER WAS INSIDE OF PATIENT DURING PROCEDURE. TIP OF CATHETER WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIONS PV 8.2 IVUS CATHETER INTRAVASCULAR ULTRASOUND CATHETER ITX VOLCANO CORP. 88900 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other