BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIOSENSE WEBSTER NAVISTAR THERMOCOOL CATHETER

    MDR report key: 739810 · Received July 24, 2006

    Report

    Report Number
    2029046-2006-00045
    Event Type
    Death
    Date Received
    July 24, 2006
    Date of Event
    November 10, 2005
    Report Date
    July 24, 2006
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DYG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS PART OF A STUDY RUN BY A FOREIGN PHYSICIAN WHICH INITIALLY WAS THOUGHT OF AS AN CLINICAL TRIAL. THE EVENT OCCURRED IN 2005 AND WAS NOT REPORTED UNTIL A FOLLOW UP ON THE STUDY ON 05/15/2006. ON 07/06/2006 WE RECEIVED ADDITIONAL INFORMATION THAT THE COMPLAINT WAS NOT PART OF ANY CLINICAL TRIAL AND SHOULD BE TREATED AS A REGULAR COMPLAINT. IT WAS DECIDED AT THIS POINT THAT THE COMPLAINT WAS MDR REPORTABLE.

    Description of Event or Problem · 1

    CARBONIZATION ON CATHETER DURING RF ABLATION OF AFIB WAS DISCOVERED. PROCEDURE WAS STOPPED IMMEDIATELY AND THE SHEATH AND CATHETER WAS REMOVED. NEUROLOGIST NOTICED ACUTE SYMPTOMS WITH RIGHT HEMI PARESIS AND DYSPHASIA DUE TO LEFT CEREBRAL MEDIA INFARCT. DOCTOR RECOMMENDED INNOHEP 175LE/KG SC. ONCE A DAY AND ORAL ANTICOAGULATION. ACUTE CT SCAN OF BRAIN WAS NORMAL. A NEW CT SCAN OF THE BRAIN IN 2005 SHOWED A BIG INFARCT AND MASSIVE EDEMA. PATIENT PASSED AWAY SEVEN DAYS LATER. NAVISTAR THERMOCOOL CATHER WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER NAVISTAR THERMOCOOL CATHETER ELECTROPHYSIOLOGICAL CATHETER DYG BIOSENSE WEBSTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Death TREATED WITH ORAL ANTICOAGULATION HEPARIN FOR| MONTHS PRIOR TO PROCEDURE.