BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER

    MDR report key: 1061157 · Received June 9, 2008

    Report

    Report Number
    1061157
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 9, 2008
    Manufacturer
    BIOSENSE WEBSTER
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    AN ERROR MESSAGE APPEARED ON THE CARTO SYSTEM STATING, "CHECK MAPPING CATHETER CONNECTION." THIS PREVENTED THE PROCEDURE FROM CONTINUING. A NEW CATHETER HANDLE WAS USED AND DID NOT FIX THE PROBLEM. THE CATHETER WAS REPLACED WITH A DUPLICATE, BRAND-NEW CATHETER. THIS FIXED THE PROBLEM. THERE WAS NOT ANY PATIENT HARM INVOLVED DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVI-STAR THERMO-COOL ELECTROPHYSIOLOGY CATHETER CATHETER, THERMAL ABLATION OAD BIOSENSE WEBSTER NA 13375742

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR