BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAPULSE PULSED FIELD ABLATION SYSTEM

    MDR report key: 19831101 · Received July 24, 2024

    Report

    Report Number
    MW5157611
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    May 29, 2024
    Report Date
    July 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    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), INC. NOTED A POTENTIAL ADVERSE EVENT REGARDING A NON-(B)(6), INC. PRODUCT. IT WAS REPORTED THAT ST-SEGMENT ELEVATION ON THE EKG WAS DISPLAYED ON THE CARTO 3 SYSTEM AND THE RECORDING SYSTEM TOWARDS THE END OF THE PROCEDURE AND DURING PFA APPLICATIONS. THE PATIENT HAD NO VISIBLE SYMPTOMS AND THEY WERE ABLE TO COMPLETE THE PROCEDURE. THE MEDICAL INTERVENTION PROVIDED WAS THAT THE PATIENT WAS GIVEN NITROGLYCERIN. THE ST ELEVATION ISSUE WAS RESOLVED AFTER 15-20 MINUTES. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. ONLY THERAPEUTIC/DIAGNOSTIC BWI PRODUCTS USED WERE THE OCTARAY CATHETER AND THE SOUNDSTAR CATHETER. THE CALLER STATED THAT THE FARAPULSE GENERATOR WAS USED FOR ABLATION. ADDITIONAL INFORMATION RECEIVED STATED USED FARAWAVE CATHETER ON ANTERIOR SIDE OF LA. 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
    534118 FARAPULSE PULSED FIELD ABLATION SYSTEM PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown