BEUDAMED
    FDA Adverse Event Other Summary report: N

    FARAWAVE CATHETER - FARAWAVE PULSED FIELD ABLATION (PFA)

    MDR report key: 22944154 · Received September 2, 2025

    Report

    Report Number
    MW5175530
    Event Type
    Other
    Date Received
    September 2, 2025
    Date of Event
    July 31, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    INITIALLY REPORTED A 116 ERROR OCCURRED AT THE TIME OF CONNECTION. THE CABLE WAS REPLACED AND THE PENTARAY NAV SH WAS REPLACED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE. ADDITIONAL INFORMATION WAS RECEIVED ON 01-AUG-2025. PATIENT IMPACT. BLOOD PRESSURE DECREASED. THERE WAS NO CARDIAC TAMPONADE OR SIMILAR ISSUES. THE PROCEDURE WAS PERFORMED WITH A FARAPULSE. NO EXTENDED HOSPITALIZATION. THE PHYSICIAN¿S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THERE WAS NO RELATIONSHIP WITH THE PRODUCT. NO ABNORMALITIES OBSERVED PRIOR TO USE OF THE PRODUCT NOR DURING USE OF THE PRODUCT. AFTER THE PROCEDURE, IT WAS CONFIRMED THAT THE PATIENT¿S BLOOD PRESSURE DECREASED. CARDIAC TAMPONADE WAS NOT CONFIRMED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335553 FARAWAVE CATHETER - FARAWAVE PULSED FIELD ABLATION (PFA) PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown