BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ STEER DS BI-DIRECTIONAL NAVIGATIONAL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CAT

    MDR report key: 1063186 · Received June 20, 2008

    Report

    Report Number
    2029046-2008-00025
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BIOSENSE WEBSTER, INC. (IRWINDALE)
    Product Code
    OAD
    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

    TWO EZ STEER CATHETERS THAT WERE INVOLVED IN THE CASE ARE ADDRESSED IN THIS REPORT. ONE CATHETER HAS BEEN REC'D FOR EVALUATION, AND ONE CATHETER WILL NOT BE RETURNED BY THE CUSTOMER. ANOTHER EZ STEER CATHETER INVOLVED IN THE CASE IS ADDRESSED IN A SEPARATE REPORT. EVALUATION SUMMARY: ONE CATHETER WAS REC'D. PER CUSTOMER, THIS CATHETER HAD LOST COMMUNICATION WITH THE CARTO SYSTEM DURING THE PROCEDURE. THE CATHETER PASSED ELECTRICAL TEST, TEMPERATURE BATH TEST, AND GENERATOR TEST. HOWEVER, THE CATHETER FAILED THE CARTO TEST AND RECALIBRATION TEST. THE GREEN TWISTED PAIR LEAD WIRES INSIDE THE BIOSENSOR CABLE DID NOT HAVE CONTINUITY. THE BIOSENSOR LEAD WIRES WERE FOUND BROKEN ABOUT 47MM BELOW THE BIOSENSOR BODY. THE LEAD WIRES WERE WRAPPED AROUND THE BIOSENSOR CABLE CAUSING THE FAILURE. COMPLAINT CONDITION WAS CONFIRMED. HOWEVER, THIS FAILURE MODE IS UNRELATED TO THE ADVERSE EVENT.

    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 DEFLECTABLE TIP CAT CATHETER PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL OAD BIOSENSE WEBSTER, INC. (IRWINDALE) D-1260-02-S 13193549A

    Patients

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