BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 1863951 · Received October 11, 2010

    Report

    Report Number
    9673241-2010-00073
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BIOSENSE WEBSTER FIELD SERVICE ENGINEER SPOKE TO THE LAB MANAGER AND SHE TOLD THAT THE ISSUE WAS NOT DUE TO THE BIOSENSE WEBSTER EQUIPMENT AND THAT THEY DID NOT NEED THE EQUIPMENT SERVICED. THE CATHETER WAS DISCARDED BY THE OR STAFF. CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: CARTO RMT V8 SYSTEM, MODEL NO.: M-5730-01, (B)(4); STOCKERT 70 SYSTEM, MODEL NO.: M-5463-01, (B)(4); COOL FLOW PUMP,U.S. SHIP KIT, MODEL NO.: M-5491-02, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CARTO XP RMT AFIB PROCEDURE, THE PHYSICIAN USER WAS ATTEMPTING TO CROSS FROM THE RIGHT ATRIUM TO THE LEFT USING A BWI THERMOCOOL EZ STEER NAV CATHETER AND PERFORATED THE HEART WITH THE CATHETER. RF ENERGY WAS NOT BEING DELIVERED AT THE TIME OF THE INJURY. THE CATHETER COULD BE VISUALIZED ON FLUORO AS BEING COMPLETELY OUTSIDE OF THE CARDIAC BORDER. THE PHYSICIAN INITIALLY UTILIZED TRANS-THORACIC ECHO TO MONITOR FOR EFFUSION, BUT THE PATIENT'S BLOOD PRESSURE DROPPED RESULTING IN EMERGENT SURGICAL INTERVENTION. THE BWI THERMOCOOL CATHETER WAS LEFT IN PLACE TO PLUG THE HOLE WHERE THE PERFORATION OCCURRED AND WENT TO THE OR WITH THE PATIENT. AN OPEN CHEST SURGERY WAS PERFORMED FOLLOWING THE SUSPECTED PERFORATION. THE AFIB PROCEDURE WAS ALREADY COMPLETED WHEN THE SUSPECTED PERFORATION OCCURRED. THE PATIENT WAS DISCHARGED HOME.

    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-1292-02-S 15204864M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R