BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2132079 · Received June 16, 2011

    Report

    Report Number
    9673241-2011-00063
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED CATHETER WAS TESTED AND PASSED ELECTRICAL TEST, TEMPERATURE BATH TEST, GENERATOR TEST, PATENCY AND FLOW RATE TEST, DEFLECTION TEST AND FOR VISUAL CHARACTERISTICS INSPECTION. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES WERE FOUND RELATED TO THIS COMPLAINT. IN ADDITION, DHR REVIEW VERIFIES THAT THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH DOCUMENTED SPECIFICATION AND PROCEDURES. THE COMPLAINT CONDITION COULD NOT BEEN CONFIRMED.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT ON DEVICE EVALUATION WILL BE SUBMITTED ONCE IT IS COMPLETED. CONCOMITANT BWI PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM, MODEL #: M-4800-01, (B)(4); COOL FLOW IRRIGATION PUMP, MODEL #: M-5491-02, (B)(4); STOCKERT RF GENERATOR, MODEL #:M-5463-01, (B)(4); LASSO 2515 NAV VARIABLE CATHETER, MODEL #: D-1290-01-S, LOT #.: 15368616L. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB CASE, IT WAS NOTICED THAT THE PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN USED X-RAY AND THE BOSTON SCIENTIFIC ICE CATHETER TO CONFIRMED PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE PATIENT WAS ADMITTED AND WAS HEMODYNAMICALLY STABILIZED. EVENT WAS NOTED TO BE POSSIBLY PROCEDURE RELATED. ALSO STATED THAT THE BWI DEVICES USED DURING THE PROCEDURE WAS REPORTED TO BE PERFORMING NORMALLY, AND NO INDICATION TO BE THE CAUSE OF THE EFFUSION.

    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 15368659M

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R