BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER OPEN-IRRIGATED ABLATION CATHETER

    MDR report key: 2112072 · Received June 2, 2011

    Report

    Report Number
    2134265-2011-02295
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE EVALUATED BY MFR.:IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION RADIOFREQUENCY ABLATION PROCEDURE, CHARRING OCCURRED. THE 7.5MM BLAZER OPEN-IRRIGATED ABLATION CATHETER WAS CONNECTED TO A NON-BSC GENERATOR AND THE TEMPERATURE WAS SET BELOW 37 DEGREES WITH A POWER SUPPLY OF 25WATTS. THE PHYSICIAN ADVANCED THE CATHETER AND SUCCESSFULLY ABLATED THE LEFT ATRIUM. THE DEVICE WAS REMOVED AND A THIN LAYER OF CHAR WAS NOTED ON THE PROXIMAL SECTION OF THE ELECTRODE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLAZER OPEN-IRRIGATED ABLATION CATHETER CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER LPB BOSTON SCIENTIFIC - SAN JOSE M004EPT9620K20

    Patients

    Seq Age Sex Outcome Treatment
    1 STOCKERT GENERATOR