BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER II HTD

    MDR report key: 1431425 · Received July 13, 2009

    Report

    Report Number
    1431425
    Event Type
    Malfunction
    Date Received
    July 13, 2009
    Date of Event
    June 4, 2009
    Report Date
    July 12, 2009
    Manufacturer
    BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN WAS USING A EPT STANDARD EXTENDED DISTAL CATHETER AND SWITCHED IT OUT FOR A EPT STANDARD DISTAL STANDARD CATHETER. THE GENERATOR PRODUCED AN ERROR WHICH STATED CHANGE CATHETER. A NEW CATHETER WAS HANDED OVER. NO HARM CAME TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II HTD CATHETER, ABLATION, CARDIAC, RF LPB BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION M0045031TL0 12418026

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR