BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE FLOPPY OO

    MDR report key: 38688 · Received September 6, 1996

    Report

    Report Number
    38688
    Event Type
    Injury
    Date Received
    September 6, 1996
    Date of Event
    August 30, 1996
    Report Date
    September 3, 1996
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PTCA AND STENT PLACEMENT, TIP OF GUIDEWIRE BROKE OFF, LODGING IN PERICARDIAL SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE FLOPPY OO GUIDEWIRE DQX ADVANCED CARDIOVASCULAR SYSTEMS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention