BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER

    MDR report key: 1905180 · Received November 22, 2010

    Report

    Report Number
    2029046-2010-00064
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 27, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THERE IS NO SUSPICION OF MALFUNCTION OF ANY BIOSENSE WEBSTER PRODUCTS IN THIS EVENT AND HE ADVISED THAT THE SYSTEM IS IN USE. CONCOMITANT BIOSENSE WEBSTER PRODUCTS USED IN THE PROCEDURE: CARTO 3 SYSTEM: MODEL NO: M-4800-01, (B)(4). STOCKERT 70 SYSTEM: MODEL NO. M-5463-01, (B)(4). COOL FLOW PUMP: MODEL NO: M-5491-02, (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER MULTIPLE ATTEMPTS TO RETRIEVE THE DEVICE, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, THUS, NO INVESTIGATION COULD BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A LEFT SIDED VT ABLATION THE PATIENT SUFFERED PERICARDIAL TAMPONADE. THE PHYSICIAN PLACED A DRAIN IN THE PERICARDIAL SPACE. THIS OCCURRED WHEN THE FIRST LESION WAS APPLIED. THEY STARTED THE ABLATION AT 35 WATTS WITH A FLOW RATE OF 30 ML PER MIN. THE POWER WAS THEN RAMPED UP TO 40 WATTS WITH A FLOW RATE OF 30 ML PER MINUTE. THERE WERE NO ERROR MESSAGES ON ANY OF THE EQUIPMENT IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BIOSENSE WEBSTER, INC (IRWINDALE) D-1294-04-S UNKNOWN_D-1294-04-S

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R