BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2572058 · Received May 11, 2012

    Report

    Report Number
    2029046-2012-00062
    Event Type
    Injury
    Date Received
    May 11, 2012
    Date of Event
    April 18, 2012
    Report Date
    April 18, 2012
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCOMITANT PRODUCTS: CARTO 3 MODEL# M-4800-01 SERIAL # (B)(4). STOCKERT MODEL# M-5463-01 SERIAL # (B)(4). COOLFLOW PUMP MODEL# M-5491-02 SERIAL # (B)(4). LASSO VARIABLE MODEL# D-1237-02-S LOT # UNKNOWN. ACUNAV MODEL# M-5723-09 LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE BLOOD PRESSURE AND OXYGEN SATURATION DROPPED AND A PERICARDIAL EFFUSION WAS NOTICED. CPR AND PERICARDIOCENTESIS WERE PERFORMED. THE PATIENT REQUIRED HOSPITALIZATION FOR ONE DAY AND DISCHARGED 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 (IRWINDALE) D-1292-04-S UNKNOWN_D-1292-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R