BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 19724333 · Received July 11, 2024

    Report

    Report Number
    2124215-2024-42805
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    June 17, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE ABLATION CATHETER THE PATIENT EXPERIENCED ATRIAL STANDSTILL. THE PULMONARY VEINS WERE ALL ABLATED WITH THE PFA CATHETER. THE CATHETER WAS THEN WITHDRAWN INTO THE SHEATH SO THE PATIENT COULD BE CARDIOVERTED. "IMMEDIATELY AFTER CARDIOVERTING ATRIAL STANDSTILL WAS OBSERVED" WITH NO P WAVES PRESENT ON THE ECG AND NO ATRIAL SIGNALS ON THE MAPPING CATHETER. THE PHYSICIAN PACED THE VENTRICLE AND ATTEMPTED PACING. THEY ATTEMPTED TO ASSESS ATRIAL ACTIVATION TWO TIMES OVER A TEN MINUTE PERIOD BEFORE THE PHYSICIAN DECIDED TO IMPLANT A PERM-TEMP PACEMAKER. THE PATIENT WAS ADMITTED OVERNIGHT FOR MONITORING. IT IS CURRENTLY UNKNOWN IF A PERMANENT PACEMAKER WILL BE IMPLANTED AND THE ISSUE IS CONSIDERED ON GOING. THE CATHETER WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE ABLATION CATHETER THE PATIENT EXPERIENCED ATRIAL STANDSTILL. THE PULMONARY VEINS WERE ALL ABLATED WITH THE PFA CATHETER. THE CATHETER WAS THEN WITHDRAWN INTO THE SHEATH SO THE PATIENT COULD BE CARDIOVERTED. "IMMEDIATELY AFTER CARDIOVERTING ATRIAL STANDSTILL WAS OBSERVED" WITH NO P WAVES PRESENT ON THE ECG AND NO ATRIAL SIGNALS ON THE MAPPING CATHETER. THE PHYSICIAN PACED THE VENTRICLE AND ATTEMPTED PACING. THEY ATTEMPTED TO ASSESS ATRIAL ACTIVATION TWO TIMES OVER A TEN-MINUTE PERIOD BEFORE THE PHYSICIAN DECIDED TO IMPLANT A PERM-TEMP PACEMAKER. THE PATIENT WAS ADMITTED OVERNIGHT FOR MONITORING. IT IS CURRENTLY UNKNOWN IF A PERMANENT PACEMAKER WILL BE IMPLANTED AND THE ISSUE IS CONSIDERED ON GOING. THE CATHETER WAS DISPOSED BY THE FACILITY AND WILL NOT BE RETURNED AS THE DEVICE PERFORMED AS EXPECTED DURING THE PROCEDURE AND THERE WERE NO REPORTS OF ANY PERFORMANCE CONCERNS. IT WAS FURTHER REPORTED THAT THE PACEMAKER WAS NOT PERMANENTLY IMPLANTED. THE PATIENT'S SINUS NODE FUNCTION HAD RECOVERED AND THUS THE PACEMAKER WAS REMOVED PRIOR TO THE PATIENT BEING DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315780 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0034110104 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Hospitalization| R