BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER¿ OPEN-IRRIGATED

    MDR report key: 2454371 · Received February 16, 2012

    Report

    Report Number
    2134265-2012-00466
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 18, 2012
    Report Date
    January 18, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. 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 ELECTROPHYSIOLOGY (EP) ABLATION PROCEDURE A STEAM POP OCCURRED. WHILE PERFORMING AN EP ABLATION TO THE LEFT ATRIUM WITH A 7.5/110/2.5 QUAD LGR BLAZER OPEN IRRIGATED CATHETER A STEAM POP WAS NOTED AFTER MULTIPLE ABLATION RUNS. THE ABLATION PARAMETERS WERE SET TO 25 WATTS AND 35°CELCIUS. THE POWER WAS REDUCED TO 20 WATTS FOLLOWING THE STEAM POP AND NO FURTHER INCIDENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THE PHYSICIAN ALSO COMMENTED THAT THE CURVE OF THE DEVICE BECAME DEFORMED DURING USE. 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 CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE M004EPT9620K20 0014380442

    Patients

    Seq Age Sex Outcome Treatment
    1