BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIRE BLU

    MDR report key: 2173088 · Received July 18, 2011

    Report

    Report Number
    2173088
    Event Type
    Malfunction
    Date Received
    July 18, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    THE ABLATION CATHETER HAS A DEFLECTING TIP AND IT STOPPED DEFLECTING DURING THE PROCEDURE. ANOTHER CATHETER WAS USED FROM THE SAME LOT AND ALSO FAILED. ABOUT 30 SECONDS AFTER USING BOTH OF THE CATHETERS, THEY STOPPED DEFLECTING. A THIRD SAFIRE BLU CATHETER WAS THEN USED SUCCESSFULLY. IT IS UNKNOWN IF IT WAS FROM THE SAME LOT. THERE NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFIRE BLU CATHETER, ABLATION, RF, CARDIAC OAD ST JUDE MEDICAL A402871 334497
    2 SAFIRE BLUE CATHETER, ABLATION, RF, CARDIAC OAD ST JUDE MEDICAL A402871 334497

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR