BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLPATH DUE CATHETER

    MDR report key: 2365812 · Received December 7, 2011

    Report

    Report Number
    2030404-2011-00326
    Event Type
    Injury
    Date Received
    December 7, 2011
    Date of Event
    November 10, 2011
    Report Date
    November 10, 2011
    Manufacturer
    STT. JUDE MEDICAL, IRVINE
    Product Code
    OAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE ROOT CAUSE CLASSIFICATION IS CONSISTENT WITH ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE IFU.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LEFT VENTRICULAR TACHYCARDIA ABLATION PROCEDURE THE PATIENT SUFFERED AN AV BLOCK. THE LEFT VENTRICULAR TACHYCARDIA WAS MAPPED USING THE ENSITE VELOCITY SYSTEM. DURING THE FIRST RF DELIVERY WITH THE COOL PATH DUE ABLATION CATHETER, AT 30 WATTS AND 40 DEGREES CELSIUS, UNDER THE MITRAL ANNULUS AN ATRIAL VENTRICULAR BLOCK OCCURRED. THE PROCEDURE WAS ENDED. TO TREAT THE AV BLOCK AN ICD WAS IMPLANTED. THERE WAS NO DEVICE MALFUNCTION REPORTED AND THE PATIENT WAS NOTED TO BE "FINE" AFTER THE EVENT. NO OTHER INFORMATION ABOUT THE PROCEDURE OR PATIENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLPATH DUE CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER OAD STT. JUDE MEDICAL, IRVINE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention