BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER II XP

    MDR report key: 2110573 · Received May 20, 2011

    Report

    Report Number
    2110573
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 20, 2011
    Manufacturer
    BOSTON SCIENTIFICTEMPERATE ABLATION CATHETER
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AN EP DOCTOR WAS PERFORMING AN ATRIAL FLUTTER ABLATION USING A BOSTON SCIENTIFIC BLAZER II XP LARGE CURVE/STD DISTAL 8 MM X 8 FR CATHETER THAT AFTER 9 ABLATIONS WAS UNABLE TO DEFLECT OR DIRECT THE TIP OF THE CATHETER IN THE BODY. THE PHYSICIAN FELT THE CATHETER WAS DEFECTIVE AND HAD STOPPED WORKING, SO HE WANTED IT REPLACED. WE SUBSTITUTED ANOTHER OF THE SAME KIND OF CATHETER TO FINISH THE PROCEDURE. THE PATIENT HAD A SUCCESSFUL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II XP CATHETER, ABLATION, RF, CARDIAC LPB BOSTON SCIENTIFICTEMPERATE ABLATION CATHETER M0044500THK20 13753666

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO OTHER THERAPIES