BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2463944 · Received February 22, 2012

    Report

    Report Number
    9673241-2012-00020
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 8, 2012
    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

    THE CONCOMITANT PRODUCTS: LASSO (DISPOSED), MODEL # D-1220-61-S, LOT # 15380888L.LASSO (DISPOSED), MODEL # D-1220-60-S, LOT # 15423474L.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE NEAR THE LEFT PULMONARY VEIN AT 15-30W, THE PATIENT'S BLOOD PRESSURE DROPPED. AN ECHO AND AN X-RAY WERE PERFORMED AND A PERICARDIAL EFFUSION WAS CONFIRMED. A PERICARDIOCENTESIS WAS PERFORMED. ACCORDING TO THE PHYSICIAN, THE CAUSALITY BETWEEN THE EVENT AND THE PRODUCT/PROCEDURE MIGHT BE POSSIBLE THAT IT WAS DUE TO THE ABLATION OR THE TIP OF THE LASSO.

    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 15477760M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R