BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER NAVISTAR THERMO-COOL

    MDR report key: 1050182 · Received May 23, 2008

    Report

    Report Number
    2029046-2008-00020
    Event Type
    Injury
    Date Received
    May 23, 2008
    Report Date
    May 21, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    DRF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INJURIES WERE REPORTED BASED ON A PRESENTATION RECEIVED DURING THE RECENT ACC (AMERICAN COLLEGE OF CARDIOLOGY) MEETING. THESE COMPLAINTS BROUGHT UP WERE LIKELY TO INVOLVE THE USE OF THE NAVISTAR THERMOCOOL CATHETER WITH THE HANSEN ROBOTIC SYSTEM. THE LABELING OF HANSEN ROBOTIC SYSTEM CONTRAINDICATES THE USE FOR ABLATION, THEREBY REPRESENTING OFF-LABEL USE. ONE OF THE COMPLICATIONS WAS A CARDIAC POP/TAMPONADE DURING ABLATION WHICH WAS SUCCESSFULLY TREATED BY PERICARDIOCENTESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER NAVISTAR THERMO-COOL CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL DRF BIOSENSE WEBSTER, INC. (IRWINDALE) NAVISTAR THERMO TC UNKNOWN-NAVISTA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening| O