BEUDAMED
    FDA Adverse Event Death Summary report: N

    BLAZER? II XP

    MDR report key: 4840532 · Received June 12, 2015

    Report

    Report Number
    2134265-2015-03781
    Event Type
    Death
    Date Received
    June 12, 2015
    Date of Event
    March 23, 2015
    Report Date
    March 23, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    OAD
    PMA / PMN Number
    P020025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE ARRHYTHMIA BEING ABLATED WAS VENTRICULAR EXTRA SYSTOLE. THE CAUSE OF TAMPONADE WAS THE HIGH TEMPERATURE AND POWER PARAMETERS USED WITH BLAZER II XP. THE PHYSICIAN CHOSE POWER MODE. THE TEMP WAS SENT AT 45; HOWEVER, THE TEMP NEVER REACHED 45 IN THE APPLICATIONS WITH USING CHILLI II ONLY REACHING BETWEEN 37-39. THE POWER IN ALL APPLICATIONS NEVER PASSED 15 W. ONE DISPERSIVE PAD WAS USED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT DEATH OCCURRED. DURING THE APPLICATION OF RF ENERGY USING A CHILLI II CATHETER, IT WAS NOTICED THAT TEMPERATURE AND POWER DID NOT REACH THE SET PARAMETERS (40 DEGREES ¿ 25W), SO THE PHYSICIAN REPLACED THE CATHETER FOR A BLAZER II XP CATHETER. THE PHYSICIAN SET THE PARAMETERS FOR THE BLAZER II XP CATHETER TO (50 DEGREES ¿ 70W). AFTER THE APPLICATION USING THE BLAZER II XP, THE PATIENT DEVELOPED CARDIAC TAMPONADE WITH A DROP IN BLOOD PRESSURE. THE CARDIAC TAMPONADE WAS TREATED WITH A CARDIAC DRAINAGE. ASYSTOLE, CARDIAC MASSAGE, AND SHOCKS WERE DELIVERED TO REVERT THE CARDIAC ARREST. SURGERY WAS COMPLETED WITH THE PATIENT ALIVE; HOWEVER THE PATIENT LATER DIED IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385079 BLAZER? II XP CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD BOSTON SCIENTIFIC - COSTA RICA (COYOL) M004EPT4500TH0

    Patients

    Seq Age Sex Outcome Treatment
    1 Death