BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5F BETA-RAIL DELIVERY CATHETER

    MDR report key: 526288 · Received February 19, 2004

    Report

    Report Number
    1062385-2004-00003
    Event Type
    Malfunction
    Date Received
    February 19, 2004
    Date of Event
    January 27, 2004
    Report Date
    February 19, 2004
    Manufacturer
    NOVOSTE CORP.
    Product Code
    MOU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE DISTAL TIP OF THE CATHETER GOT STUCK AT THE TREATMENT SITE. THE CATHETER STUCK ON THE GUIDEWIRE AND PULLED OUT TOGETHER WITH THE GUIDEWIRE CAUSING A DISSECTION OF THE PROXIMAL LAD. THE DR. PLACED A STENT AT THE DISSECTED SITE AND CONTINUED NORMAL PTCA. THE PT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5F BETA-RAIL DELIVERY CATHETER CATHETER MOU NOVOSTE CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other