BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GALVANIZE PFA CATHETER / CENTAURI SYSTEM

    MDR report key: 22131109 · Received June 2, 2025

    Report

    Report Number
    MW5170997
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 29, 2025
    Manufacturer
    GALVANIZE THERAPEUTICS
    Product Code
    OCM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE BE ADVISED THAT WHILE INVESTIGATING AN EVENT INVOLVING ONE OF OUR PRODUCTS, (B)(6) NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6) PRODUCT. AFTER THE FIRST PFA ABLATION (GALVANIZE) IN THE RVOT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE. A TAMPONADE WAS CONFIRMED. A DRAIN WAS PLACED AND THE PATIENT WAS STABILIZED FOR TRANSPORT TO ICU. 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
    362592 GALVANIZE PFA CATHETER / CENTAURI SYSTEM SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION OCM GALVANIZE THERAPEUTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown