BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 3010434 · Received March 19, 2013

    Report

    Report Number
    2029046-2013-00032
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    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
    IL, 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 #UNKNOWN. COOLFLOW PUMP MODEL# M-5491-02, SERIAL #UNKNOWN. SOUNDSTAR ECO MODEL# M-5723-15, LOT# UNKNOWN. LASSO SAS MODEL# D-1312-01-S, LOT# UNKNOWN. MANUFACTURER REF # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN AFIB PROCEDURE, THE PATIENT WENT HYPOTENSIVE AFTER ABLATION AND HAD TO HAVE A PERICARDIOCENTESIS PERFORMED. THE CATHETERS WERE DISPOSED OF. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114636 EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1292-05-S UNKNOWN_D-1292-05-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R