BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER¿ OPEN-IRRIGATED

    MDR report key: 2453348 · Received February 15, 2012

    Report

    Report Number
    2134265-2012-00465
    Event Type
    Malfunction
    Date Received
    February 15, 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 ABLATION PROCEDURE A STEAM POP OCCURRED. WHILE PERFORMING AN EP ABLATION TO THE RIGHT VENTRICLE WITH A 7.5/110/2.5 QUAD LGR BLAZER OPEN IRRIGATED CATHETER AFTER ABOUT 90 SECONDS AT 50°C AND 35 WATTS A POP WAS HEARD ON THE FIRST ABLATION. THE POWER WAS REDUCED TO 30 WATTS ON THE SECOND ABLATION FOR 1,000 SECONDS AND NO FURTHER INCIDENT OCCURRED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 0014390538

    Patients

    Seq Age Sex Outcome Treatment
    1