BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 2083070 · Received May 10, 2011

    Report

    Report Number
    9673241-2011-00044
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 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
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED BY THE CUSTOMER. THEREFORE, NO EVALUATION WAS PERFORMED. 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: CARTO 3 SYSTEM, US CAT NUM: M480001, (B)(4); STOCKERT 70 RF GENERATOR, US CAT NUM: S7001, (B)(4); COOLFLOW IRRIGATION PUMP, US CAT NUM: CFP002, (B)(4); PREFACE GUIDING SHEATH WITH MULTIPURPOSE CURVE, US CAT NUM: 301803M, LOT NUM: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN A-FIB PROCEDURE, PATIENT SUFFERED A CARDIAC TAMPONADE WHILE UNDERGOING ABLATION. PERICARDIOCENTESIS WAS PERFORMED AND WAS TRANSFERRED TO THE CRITICAL CARE UNIT. PATIENT LEFT THE PROCEDURE ROOM IN STABLE CONDITION. ACCORDING TO THE CUSTOMER, CAUSALITY OF THE ADVERSE EVENT WAS PROCEDURE RELATED.

    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 15347234M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R