BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2073352 · Received May 1, 2011

    Report

    Report Number
    9673241-2011-00041
    Event Type
    Injury
    Date Received
    May 1, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    OAD
    PMA / PMN Number
    P030031
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON FURTHER CLARIFICATION FROM THE FACILITY, THE PHYSICIAN HAS INDICATED THAT THE PATIENT'S PROGNOSIS IS SATISFACTORY. THE ADVERSE EVENT WAS NOT CAUSED BY THE (B)(4) PRODUCT INVOLVED IN THE PROCEDURE. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE PATIENT'S HEALTH CONDITIONS. IF THE PRODUCT IS RETURNED TO (B)(4) IN THE FUTURE, AN ANALYSIS WILL BE PERFORMED AND A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, A CARDIAC TAMPONADE HAD DEVELOPED DURING ABLATION IN THE LEFT AURICLE (30W/30SEC, IRRIGATION 17MM/MIN.). THE PHYSICIAN STOPPED ABLATION DUE TO THE BLOOD PRESSURE REDUCTION TO 40MMHG. AFTER DRAINAGE AND PROTAMINE ADMINISTRATION, BLOOD PRESSURE INCREASED TO 120MMHG. THE PATIENT WAS TRANSFERRED TO ICU AFTER AN HOUR FOLLOW UP IN OPERATING ROOM. THE PATIENT IS CURRENTLY FOLLOWED UP AND IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC. (JUAREZ) D-1292-05-S 15279678M

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R