BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOCOOL DEFLECTABLE CATHETER

    MDR report key: 236378 · Received August 12, 1999

    Report

    Report Number
    2020638-1999-00020
    Event Type
    Death
    Date Received
    August 12, 1999
    Date of Event
    March 1, 1999
    Report Date
    July 13, 1999
    Manufacturer
    CORDIS WEBSTER, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN AN "IDE" CLINICAL STUDY, A PERICARDIAL TAMPONADE OCCURRED DURING ABLATION OF AN EPICARDIAL POSTEROSEPTAL ACCESSORY PATHWAY PATIENT ON 09/21/98. THE PATIENT UNDERWENT AN EMERGENCY THORACOTOMY TO REPAIR THE RIGHT VENTRICULAR PERFORATION. HE SUFFERED ANOXIC ENCEPHALOPATHY AND REMAINED IN A COMA THROUGHOUT THE HOSPITAL STAY. AS OF 12/01/98, THE PATIENT CONTINUED TO REMAIN VENTILATOR DEPENDENT, IN A VEGETATIVE STATE WITH NO SIGNIFICANT NEUROLOGICAL IMPROVEMENT. THE FAMILY REQUESTED A DO NOT RESUSCITATE STATUS FOR HIM. IN EARLY MARCH, THE FAMILY REQUESTED ALL LIFE SUPPORT TO BE WITHDRAWN. PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMOCOOL DEFLECTABLE CATHETER ABLATION CATHETER MCX CORDIS WEBSTER, INC. D1189-17-SI 807504

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death STOPPED.