BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2083051 · Received May 10, 2011

    Report

    Report Number
    9673241-2011-00043
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED FOR EVALUATION. BWI FIELD SERVICE ENGINEER CONTACTED THE CUSTOMER TO SCHEDULE SERVICE/EVALUATION OF THE EQUIPMENT INVOLVED. CUSTOMER REFUSED SERVICE AND STATED THAT THE EVENT WAS NOT CAUSED BY THE BWI EQUIPMENT AND NO FURTHER ACTION REQUIRED. BWI CONCOMITANT PRODUCTS: STOCKERT 70 RF GENERATOR, US CAT NUM: S7001, (B)(4); COOLFLOW IRRIGATION PUMP, US CAT NUM: CFP002, (B)(4); CARTO 3 SYSTEM, US CAT NUM M480001, (B)(4); EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER , US CAT NUM: BNI75TCDFH, (B)(4). (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE PHYSICIAN WAS PERFORMING A 60 SECOND ABLATION AT 50 WATTS WHEN HE HEARD A STEAM POP AT 58 SECONDS DURING ABLATION. PATIENT'S BLOOD PRESSURE DROPPED. THE PHYSICIAN CONFIRMED PERICARDIAL EFFUSION THROUGH ULTRASOUND. A PERICARDIOCENTESIS WAS PERFORMED AND THE PATIENT STABILIZED. THE PHYSICIAN CONTINUED THE CASE. PATIENT WAS IN STABLE CONDITION. AFTER MULTIPLE FOLLOW-UPS, NO ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

    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 15341811M

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R