BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAPULSE PFA SYSTEM AND FARAWAVE PULSED FIELD ABLATION (PFA) SYSTEM

    MDR report key: 22204678 · Received June 13, 2025

    Report

    Report Number
    MW5171465
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 19, 2025
    Report Date
    June 10, 2025
    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

    IT WAS REPORTED DURING AN AFIB CASE, A PERICARDIAL EFFUSION WAS NOTICED. CALLER REPORTED THAT THERE WAS A DROP IN BLOOD PRESSURE ON THE PATIENT. THE PERICARDIAL EFFUSION WAS CONFIRMED BY THE SOUNDSTAR IMAGING CATHETER. CALLER NOTED THAT THE MEDICAL INTERVENTION PROVIDED WAS "PROTAMINE AND MEDICATION TO KEEP THE BLOOD PRESSURE UP". THE LAST KNOWN STATUS OF THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION WHEN SHE LEFT YESTERDAY. CALLER STATED SHE WILL FOLLOW UP WITH THE PATIENT STATUS AND THE MEDICATION THAT WAS ADMINISTERED TO THE PATIENT TODAY. THE CALLER STATED THE PHYSICIAN WAS NOT CERTAIN WHAT CAUSED THE INJURY. CALLER DECLINED FSE FOLLOW UP. THE ONLY BWI CATHETERS IN THE BODY AT THE TIME OF THE INJURY WAS A SOUNDSTAR CATHETER (UNKNOWN LOT #) AND A OCTARAY CATHETER (LOT #31593024L - REF- D160906). BOTH CATHETERS ARE AVAILABLE TO RETURN. THE CARTO 3 SYSTEM WAS ONLY USED FOR MAPPING. 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
    1009225 FARAPULSE PFA SYSTEM AND FARAWAVE PULSED FIELD ABLATION (PFA) SYSTEM PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown OCTARAY CATHETER - LOT 31593024L ¿ REF D160906.| SOUNDSTAR CATHETER - LOT: UNKWNOWN - REF: UNKNOWN.