BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER DS BI-DIRECTIONAL NAVIGATIONAL DIAGNOSTIC/ABLATION

    MDR report key: 1063185 · Received June 20, 2008

    Report

    Report Number
    9673241-2008-00029
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (JUAREZ)
    Product Code
    DRF
    PMA / PMN Number
    P010068/S6
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE EZ STEER CATHETER INVOLVED IN THE CASE IS ADDRESSED IN THIS REPORT. TWO OTHER EZ STEER CATHETERS INVOLVED IN THE CASE ARE ADDRESSED IN A SEPARATE REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SKIN BURN WAS FOUND AT THE INDIFFERENT ELECTRODE SITE DURING A PROCEDURE USING A VALLEY LAB SPLIT ELECTRODE, A STOCKERT RF GENERATOR AND THREE EZ STEER CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EZ STEER DS BI-DIRECTIONAL NAVIGATIONAL DIAGNOSTIC/ABLATION CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF A DRF BIOSENSE WEBSTER, INC. (JUAREZ) D-1260-04-S 13368813

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other VALLEY LAB SPLIT ELECTRODE| STOCKERT RF GENERATOR| CARTO SYSTEM