BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAZER? OPEN-IRRIGATED

    MDR report key: 3545529 · Received December 31, 2013

    Report

    Report Number
    2134265-2013-09411
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    May 12, 2013
    Report Date
    December 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SAN JOSE
    Product Code
    LPB
    PMA / PMN Number
    SIMILAR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: UNDER 18 YEARS. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 STEAM POPS OCCURED. A 7.5X110X2.5 OPEN IRRIGATED QUAD LGR WAS SELECTED TO TREAT THE TARGET LESION FOR A FLUTTER ABLATION PROCEDURE WITH SETTINGS OF 40ºC AND 40 WATTS. DURING THE PROCEDURE, IT WAS OBSERVED THAT 3 STEAM POPS OCCURED. NO CHAR OR COAGULUM WAS NOTED ON THE CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682098 BLAZER? OPEN-IRRIGATED CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BOSTON SCIENTIFIC - SAN JOSE M004EPT9620K20 16295927

    Patients

    Seq Age Sex Outcome Treatment
    1