BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 1343955 · Received December 31, 2008

    Report

    Report Number
    1343955
    Event Type
    Death
    Date Received
    December 31, 2008
    Date of Event
    December 26, 2008
    Report Date
    December 29, 2008
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DURING CATHETERIZATION PROCEDURE, TIP OF INTERVENTIONAL WIRE BROKE OFF IN THE DISTAL CIRCUMFLEX ARTERY. PATIENT SUFFERED CARDIAC ARREST DURING PROCEDURE AND WAS UNABLE TO BE STABILIZED OR RESUSCITATED. UNKNOWN AS TO THE EXTENT WIRE FAILURE CONTRIBUTED TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT INTERVENTIONAL GUIDEWIRE DQX ABBOTT VASCULAR 0.014" 190 CM 8103181

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death