BEUDAMED
    FDA Adverse Event Death Summary report: N

    DVI 7 FRENCH ATHERECTOMY CATHETER

    MDR report key: 25820 · Received August 11, 1995

    Report

    Report Number
    25820
    Event Type
    Death
    Date Received
    August 11, 1995
    Date of Event
    August 7, 1995
    Report Date
    August 10, 1995
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION, INC.
    Product Code
    MCX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE OF DIRECTIONAL CORONARY ATHERECTOMY OF PROXIMAL ANTERIOR DESCENDING, THE (L) MAIN CORONARY ARTERY DISSECTED AND OCCLUDED WHICH PRECIPITATED CARDIAC ARREST. INTRA-AORTIC BALLOON WAS PLACED IN (L) GROIN. A TEMPORARY ARTERY GRAFT X 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DVI 7 FRENCH ATHERECTOMY CATHETER ATHERECTOMY CATHETER MCX DEVICES FOR VASCULAR INTERVENTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death