BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER II XP ABLATION CATHETER

    MDR report key: 1202944 · Received October 17, 2008

    Report

    Report Number
    2953184-2008-00034
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC, ELECTROPHYSIOLOGY
    Product Code
    LPB
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER WAS VISUALLY INSPECTED AND VERIFIED NORMAL. DURING FUNCTIONAL TESTING, THE CATHETER FUNCTIONED AS EXPECTED DURING ELECTRICAL TESTING INVESTIGATION. THE RIGHT AND LEFT STEERING CURVES MET THE SPEC. REVIEW OF MFG RECORDS FOUND NO ISSUES RELATED TO THE EVENT. A 15 MONTH REVIEW OF COMPLAINTS FOR THE PROD FAMILY FOUND NO NEGATIVE TREND. REVIEW OF LABELING PERFORMED; EFFUSION (PERICARDIAL / PLEURAL) IS LABELED AS A POTENTIAL ADVERSE EVENT. EVENT RELATED TO MDR # 2953184-2008-00035.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO BSC; DURING A PROCEDURE, WE NOTICED THE PT'S HEART RATE WAS SLOWING, THE PHYSICIAN IMMEDIATELY PUT THE ACCUNAV CATHETER BACK IN AND NOTICED A SMALL EFFUSION. THE PT'S HEART RATE AND O2 SATURATION DROPPED FURTHER, AND THE PT WAS TAKEN TO SURGERY AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II XP ABLATION CATHETER TEMPERATURE ABLATION CATHETER LPB BOSTON SCIENTIFIC, ELECTROPHYSIOLOGY 4500THK2 11751974

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BLAZER II CATHETER| MAESTRO GENERATOR| ST JUDE DIAGNOSTIC CATHETER