BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER

    MDR report key: 1766261 · Received July 21, 2010

    Report

    Report Number
    2029046-2010-00034
    Event Type
    Injury
    Date Received
    July 21, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 29, 2010
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE CATHETER WAS DISCARDED BY THE CUSTOMER AND NOT RETURNED TO BIOSENSE WEBSTER FOR INVESTIGATION. CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: CARTO 3 SYSTEM (B) (4), MODEL NO. M-4800-01 (B) (4); STOCKERT 70 SYSTEM (ST-1934), MODEL NO. M-5463-01 (B) (4); 3. COOL FLOW PUMP (B) (4), MODEL NO. M-5491-02. (B) (4); C3 NAV VARIABLE LASSO CATALOG NO. LN222515CT LOT NO.: UNKNOWN; EZ STEER CORONARY SINUS CATALOG NO.BD710FJ282RT LOT NO.: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE AFIB CASE, THE PATIENT'S BLOOD PRESSURE DROPPED, AN ICE WAS PERFORMED WHICH SHOWED PERICARDIAL EFFUSION. THE PATIENT HAD A PERICARDIAL DRAIN PLACEMENT. THE PERICARDIAL DRAIN WAS REMOVED ON (B) (6)2010. THE PATIENT HAD AN ECHO ON (B) (6)2010 CONFIRMING NO PERICARDIAL EFFUSION. THE PATIENT WAS DISCHARGED ON (B) (6)2010.

    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 (IRWINDALE) D-1292-04-S UNKNOWN_D-1292-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R