BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2083417 · Received May 10, 2011

    Report

    Report Number
    2029046-2011-00041
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 10, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER REPORTED THAT BLOOD PRESSURE BEGAN TO DECREASE DURING THE ABLATION (WITH 30W) IN LSPV RIDGE. PERICARDIAL EFFUSION WAS OBSERVED BY ECHO. DRAINAGE WAS PERFORMED. THE PHYSICIAN COMMENTED THE CAUSE OF THE EVENT WAS UNKNOWN. THE RETURNED CATHETER WAS TESTED AND PASSED ELECTRICAL, LEAKAGE, TEMPERATURE, STOCKERT GENERATOR, PATENCY FLOW, COOL FLOW PUMP AND DEFLECTION TESTS. THE DEVICE HISTORY RECORD COULD NOT BEEN REVIEWED SINCE THE LOT # OF THIS PRODUCT WAS NOT PROVIDED. COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLOOD PRESSURE BEGAN TO DECREASE DURING THE ABLATION (WITH 30W) IN LSPV RIDGE. PERICARDIAL EFFUSION WAS OBSERVED BY ECHO. DRAINAGE WAS PERFORMED. THE PHYSICIAN COMMENTED THE CAUSE OF THE EVENT WAS UNKNOWN.

    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-1292-01-S UNKNOWN_D-1292-01-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R