BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORDIS CORPORATION

    MDR report key: 115514 · Received June 20, 1997

    Report

    Report Number
    115514
    Event Type
    Injury
    Date Received
    June 20, 1997
    Date of Event
    March 11, 1997
    Report Date
    March 20, 1997
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT DEVELOPED ACUTE MI CARDIOGENIC SHOCK DURING CARDIAC CATHETERIZATION PROCEDURE. EMERGENCY INTRAAORTIC BALLOON COUNTER PULSATION INFLATED FOLLOWED BY PTCA/STENT DEPLOYMENT FOR OCCLUSION LEFT MAIN CORONARY ARTERY. GUIDE WIRE FRACTURE EVIDENT ON COMPLETION. CORONARY INTERVENTIONAL PROCEDURE AND FRAGMENT REMOVED USING SNARE DEVICE. PT DEVELOPED ACUTE CARDIAC TAMPONADE AND INITIALLY STABILIZED FOLLOWING EMERGENCY PERICARDIOCENTESIS. REQUIRED EMERGENCY CABG BECAUSE OF CARDIAC TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORDIS CORPORATION CORONARY GUIDEWIRE DQX CORDIS CORPORATION * H0296057

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R