BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER II HTD

    MDR report key: 1640684 · Received March 18, 2010

    Report

    Report Number
    1640684
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    March 17, 2010
    Report Date
    March 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BLAZER II HTD ABLATION CATHETER WAS TESTED PRIOR TO INSERTION INTO THE BODY AND THE MECHANISM WAS MOVING CORRECTLY. A FEW MINUTES AFTER INSERTION WHILE ATTEMPTING TO MAP THE RIGHT VENTRICLE, THE CATHETER BECAME DIFFICULT TO MANEUVER IN THE HEART AND WAS REMOVED FROM THE BODY. THERE WAS NO DIFFICULTY WITH THE PATIENT'S ANATOMY. WHILE ON THE TABLE IT WAS NOTICED THAT THE LAST 1" OF THE DISTAL TIP OF THE CATHETER APPEARED TO BE BENT IN AN ODD POSITION AND THE CATHETER COULD NOT BE MOVED CORRECTLY. A NEW CATHETER WAS INSERTED AND THE PROCEDURE CONTINUED WITH A SUCCESSFUL OUTCOME. THE PHYSICIAN FREQUENTLY USES THIS PRODUCT AND HAS NEVER SEEN THIS TYPE OF PROBLEM BEFORE. ====================== HEALTH PROFESSIONAL'S IMPRESSION======================IT APPEARED THAT THE CATHETER MAY HAVE BECOME BENT OR BROKEN WITHIN THE GREY PLASTIC COATING OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II HTD CATHETER, ABLATION, RF, CARDIAC LPB BOSTON SCIENTIFIC M0045031TH 12897596

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR NO OTHER THERAPIES