BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOSENSE WEBSTER NAVISTAR/CELCIUS THERMO-COOL

    MDR report key: 1033841 · Received April 24, 2008

    Report

    Report Number
    2029046-2008-00012
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 4, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PERFORATION TO THE LEFT ATRIAL APPENDAGE DURING AN ABLATION PROCEDURE. FOLLOWING CARDIOVERSION OF THE CASE, PT HAD A DECREASE IN BOTH HEART RATE AND BLOOD PRESSURE. APPROX AN HR LATER, A CARDIAC REPAIR SURGERY FOR PERFORATION WAS PERFORMED AND PT WAS PUT ON A VENTILATOR. PT WAS TAKEN TO ICU FOR OBSERVATION. PROGNOSIS WAS EXCELLENT AND PT FULLY RECOVERED. CAUSE OF ADVERSE EVENT WAS PROCEDURE RELATED. COMPANY REP WAS NOT NOTIFIED OF THE EVENT UNTIL DAYS LATER. THE CATHETER WAS NOT SAVED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSENSE WEBSTER NAVISTAR/CELCIUS THERMO-COOL CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL OAD BIOSENSE WEBSTER, INC. (IRWINDALE) D-1197-17-S UNK_D-1197-

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R