BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 3870144 · Received June 6, 2014

    Report

    Report Number
    MW5036529
    Event Type
    Death
    Date Received
    June 6, 2014
    Date of Event
    April 22, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR PVC ABLATION. HE HAD ABLATION DONE UNDER CONSCIOUS SEDATION ON (B)(6). ABLATION START TIME WAS 2:04 PM. CASE UNEVENTFUL UNTIL 2:33 PM WHEN A CHANGE IN PT STATUS WAS NOTED BY A CHANGE IN VITAL SIGNS. (BIOSENSE WEBSTER CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER WAS ADVANCED AT 2:25 PM) ECHO CONFIRMED LARGE PERICARDIAL EFFUSION. ATTEMPTS AT DRAINING THE EFFUSION WERE NOT SUCCESSFUL AS IT WAS CLOTTED OFF. HE WAS INTUBATED AND ACLS PROTOCOL INSTITUTED IMMEDIATELY AND SURGICAL ASSISTANCE WAS OBTAINED. CARDIOVASCULAR SURGEONS WERE ABLE TO DO OPEN STERNOTOMY AND EVACUATION OF CLOT AND BLEED FROM PERICARDIAL SPACE AND RESUSCITATE PT (DIAGNOSIS -RIGHT VENTRICULAR OUTFLOW TRACK PERFORATION). PT WAS IN THE ICU AND REQUIRED TO GO TO THE OPERATING ROOM AGAIN FOR REMOVAL OF SPONGES AND CLOSING OF STERNUM ON (B)(6). HE REQUIRED MULTIPLE PRESSORS INITIALLY WHICH WERE BEING WEANED. CRITICAL CARE AND CARDIOLOGY PHYSICIANS WERE CONSULTED FOR HYPOTHERMIA PROTOCOL. HE WAS "WARMED" ON (B)(6) AND HAD SUBSEQUENT CT OF HIS HEAD AND THEN NEUROLOGY CONSULT WHICH SHOWED SEVERE IRREVERSIBLE ANOXIC BRAIN INJURY AND FURTHER CARE WAS DEEMED TO BE UNLIKELY TO IMPROVE OUTCOME. HE PASSED AWAY ON (B)(6), AT 23:06 WITH FAMILY AT BEDSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332532 CELSIUS THERMO-COOL ELECTROPHYSIOLOGY CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION DRF BIOSENSE WEBSTER 35Q73R 15686501M

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death BENADRYL| VERSED| FENTANYL| ISUPREL| PHENERGAN