BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER

    MDR report key: 1886905 · Received November 1, 2010

    Report

    Report Number
    2029046-2010-00058
    Event Type
    Injury
    Date Received
    November 1, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER DECLINED SERVICE TO THE BIOSENSE WEBSTER EQUIPMENT. MULTIPLE FOLLOW UPS WERE MADE TO RETRIEVE THE PRODUCT, BUT THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. IF THE PRODUCT IS RETURNED IN THE FUTURE, AN ANALYSIS WILL BE PERFORMED AND A SUPPLEMENTAL WILL BE SUBMITTED. CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED DURING THE PROCEDURE: CARTO 3 RMT SYSTEM: MODEL NO: M-5830-01, (B)(4). COOL FLOW PUMP: MODEL NO: M-5491-02, (B)(4). STOCKERT 70 SYSTEM: MODEL NO: M-5463-01, (B)(4). LASSO 2515 NAV VARIABLE CATHETER: CATALOG NO: LN222515CT, LOT NO: 15230737L. SOUNDSTAR CATHETER: CATALOG NO: SNDSTR10G, LOT NO: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING AN AFIB ABLATION THE PATIENT SUFFERED A PERICARDIAL EFFUSION AND A PERICARDIOCENTESIS HAD TO BE PERFORMED. THE PHYSICIAN WAS LONG INTO THE PROCEDURE WITH 900 POINTS ON THE MAP. AT THE END OF THE CASE, THE PATIENT WAS STABLE AND WAS SENT TO THE ICU. IT WAS ALSO REPORTED THAT THERE WAS NO INDICATION THAT ANY OF THE BIOSENSE WEBSTER EQUIPMENT THAT WAS IN USE WAS AT FAULT.

    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-1292-04-S UNKNOWN_D-1292-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R