BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEZOR XTRA 3 CARDIAC CRYOABLATION CATHETER

    MDR report key: 1053153 · Received May 19, 2008

    Report

    Report Number
    1053153
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 18, 2008
    Manufacturer
    CRYOCATH TECHNOLOGIES INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DR. FOUND THAT THE CATHETER HAD A DEFECT WITH THE DISTAL TIP. THE DISTAL TIP WAS "KINKED." THE CATHETER WAS RETRIEVED AND REPLACED WITH ANOTHER CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREEZOR XTRA 3 CARDIAC CRYOABLATION CATHETER CATHETER, ABLATION LPB CRYOCATH TECHNOLOGIES INC. NA 02529

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR CARDIAC DRUGS| CARDIAC DRUGS