BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAZER II XP

    MDR report key: 1807543 · Received August 19, 2010

    Report

    Report Number
    3001236349-2010-00040
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    August 14, 2007
    Report Date
    August 29, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR ANALYSIS /INVESTIGATIONS. THIS EVENT WAS PREVIOUSLY REPORTED ON MDR 2953184-2007-00020 ON (B)(4) 2007 FOR THE GROUND PAD USED IN THIS EVENT. THIS REPORT IS FOR THE ABLATION CATHETER USED IN THIS EVENT. THE CATHETER CAN NOT CAUSE THE BURNS ON THE SHOULDER BLADE AS INDICATED IN THE EVENT DESCRIPTION (2 SQ. CENTIMETERS), AS THE CATHETER IS INSIDE THE PATIENT DURING RF ABLATION. PER THE COMPLAINT EVENT, THE BLAZER CATHETER NEVER CAME IN CONTACT WITH THE PATIENT'S SKIN; THEREFORE, IT WAS NOT A DIRECT CONTRIBUTOR IN CAUSING THE BURN. THE DEVICE WAS DISCARDED AND BASED ON THE LIMITED INFORMATION RECEIVED REGARDING THIS EVENT, THE SPECIFIC ROOT CAUSE OF THE BURN CANNOT BE DETERMINED. HOWEVER, NUMEROUS POSSIBLE CAUSES FOR THE BURN EXIST, INCLUDING BUT NOT LIMITED TO: INADEQUATE SKIN PREPARATION, IMPROPER APPLICATION OF THE PADS, PADS PLACED OVER THE ADIPOSE TISSUE, SCAR TISSUE, BONY PROMINENCE, PADS MAY HAVE BECOME DISLODGED DUE TO PATIENT MOVEMENT, AND OTHERS. PRECAUTIONS ARE INDICATED IN THE EPT-1000XP OPERATOR'S MANUAL TO READ AND FOLLOW THE DISPERSIVE INDIFFERENT PATCH (DIP) ELECTRODE MANUFACTURER'S INSTRUCTIONS FOR USE. IT IS ALSO INDICATED IN THE MANUAL TO CHECK THAT GROUND PADS ARE PROPERLY APPLIED AND THAT CONNECTIONS ARE SECURE PRIOR TO RF DELIVERY. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    PATIENT BURN OF 2 SQUARE CENTIMETER DISCOVERED 2 DAYS AFTER A RADIOFREQUENCY SESSION (5 RF DELIVERED). THE BURN WAS LOCALISED UNDER THE LEFT SHOULDER BLADE, IN THE MIDDLE OF THE PATIENT ELECTRODE.PATIENT WAS TREATED BY ALGOPLAQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER II XP CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC M004EPT4500THN40 BATCH_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 GROUND PAD VALLEY LAB-354 (2953184-2007-00020)| (B)(4) GENERATOR (3001236349-2010-00039)