BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLCANO CORPORATION

    MDR report key: 2367550 · Received September 10, 2007

    Report

    Report Number
    2367550
    Event Type
    Injury
    Date Received
    September 10, 2007
    Date of Event
    March 9, 2007
    Report Date
    September 7, 2007
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MULTI STENT PROCEDURE. THE STENT HAD ALREADY BEEN PLACED. THE IVUS WAS INSERTED VIA A CATHETER AND IN DOING SO IT BECAME LODGED BETWEEN THE STENT AND THE OUTSIDE WALL OF THE ARTERY. NUMEROUS ATTEMPTS TO DISLODGE THE DEVICE WERE ATTEMPTED AND FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOLCANO CORPORATION IVUS CATHETER IYO VOLCANO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other| S