BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER II XP

    MDR report key: 511624 · Received January 16, 2004

    Report

    Report Number
    2939222-2004-00001
    Event Type
    Malfunction
    Date Received
    January 16, 2004
    Date of Event
    March 10, 2003
    Report Date
    March 14, 2003
    Manufacturer
    EP TECHNOLOGIES, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED IN 2003 FOR A BLAZER II XP ABLATION CATHETER BREAKING AT THE SECOND ELECTRODE. THE MALFUNCTION WAS NOTICED DURING THE CARDIAC ABLATION PROCEDURE, WITH NO REPORT OF INJURY TO THE PT. THE INVESTIGATION WAS ORIGINALLY CLOSED IN 2003 AFTER PRODUCT HAD NOT BEEN RETURNED. THERE WAS NOTHING TO INDICATE POTENTIAL FOR PT INJURY AT THIS TIME. THE PRODUCT WAS SUBSEQUENTLY RETURNED AND ANALYZED IN 2003. THE EXAM REVEALED A PROTRUDING WIRE FROM THE STEERING MECHANISM. THE CLASSIFICATION OF THIS DEVICE MALFUNCTION AS HAVING POTENTIAL FOR PT INJURY WAS MADE THE NEXT DAY. THE CAUSE OF THE DEVICE MALFUNCTION IS UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II XP CARDIAC ABLATION CATHETER LPB EP TECHNOLOGIES, INC. 4500THN4 5205308

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN