BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 2112190 · Received June 2, 2011

    Report

    Report Number
    9673241-2011-00056
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 5, 2011
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    LPB
    PMA / PMN Number
    P990025/S12
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACILITY INDICATED THAT THE PATIENT INJURY HAD NOTHING TO DO WITH ANY BWI PRODUCTS AND NO SERVICE IS REQUESTED AT THIS TIME. THE DISPOSABLE PRODUCTS HAVE BEEN DISCARDED. NO ADDITIONAL INFORMATION ABOUT THE PATIENT OR THE PROCEDURE HAS BEEN PROVIDED BY THE FACILITY. IF THE FACILITY REQUESTS SERVICE, RETURNS THE PRODUCTS, OR PROVIDES MORE INFORMATION, A 3500A SUPPLEMENTAL WILL BE SUBMITTED TO THE FDA AS REQUIRED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, CATALOG # M480001, (B)(4); STOCKERT 70 RF GENERATOR, CATALOG # S7001, (B)(4); COOLFLOW IRRIGATION PUMP, CATALOG # CFP002, (B)(4); SOUNDSTAR 10F-90 GE, CATALOG # SNDSTR10, LOT # UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN AFIB ABLATION THE PATIENT SUFFERED PLEURAL EFFUSION. THE PATIENT WAS TAKEN TO SURGERY FOR THE LIQUID TO BE DRAINED AND A HEMATOMA TO BE EVACUATED. THERE WAS NO INDICATION THAT ANY BWI EQUIPMENT FAILED OR WAS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION LPB BIOSENSE WEBSTER, INC. (JUAREZ) D-1268-05-S 15347165M

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R