BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 19924490 · Received August 6, 2024

    Report

    Report Number
    2124215-2024-48761
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 8, 2024
    Report Date
    November 19, 2024
    Manufacturer
    FARAPULSE, INC.
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. BASED UPON ANALYSIS OF ALL AVAILABLE INFORMATION, BSC'S INVESTIGATION FOUND NO EVIDENCE TO INDICATE THAT THE ATRIAL FLUTTER WAS RELATED TO PRODUCT PERFORMANCE OF THE FARAWAVE CATHETER. THERE WAS NO REPORT OF ANY DEVICE PERFORMANCE CONCERNS. THE PATIENT EVENTS REPORTED IN THE COMPLAINT ARE KNOWN POTENTIAL ADVERSE EVENTS RELATED WITH THE USE OF THE DEVICE AND ARE NOTED WITHIN THE INDICATIONS/INSTRUCTIONS FOR USE (IFU). THEREFORE, ALL COMPILED INFORMATION ON THIS INVESTIGATION DETERMINES THAT THE MOST PROBABLE CAUSE IS KNOWN INHERENT RISK OF DEVICE SINCE THE COMPLAINT PATIENT EVENTS REPORTED BY THE PHYSICIAN IS KNOWN AND DOCUMENTED IN THE LABELING. THE FARAWAVE'S INSTRUCTIONS FOR USE STATE "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH USE OF THE FARAWAVE CATHETER INCLUDES, BUT ARE NOT LIMITED TO: ARRYTHMIA."

    Description of Event or Problem · 0

    PF114 FARADISE CLINICAL STUDY, SUBJECT ID: (B)(6) IT WAS REPORTED THAT FOLLOWING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER THE PATIENT DEVELOPED ATYPICAL ATRIAL FLUTTER. APPROXIMATELY 7 MONTHS AFTER THE PROCEDURE THE PATIENT WAS HOSPITALIZED DUE TO ATYPICAL ATRIAL FLUTTER. AN EP STUDY ALONG WITH AN ABLATION PROCEDURE WAS PERFORMED WHILE THE PATIENT WAS HOSPITALIZED. THE ABLATION WAS PERFORMED ON THE 3RD DAY OF HOSPITALIZATION AND THE PATIENT WAS DISCHARGED THAT SAME DAY WITH NO FURTHER COMPLICATIONS. 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

    PF114 FARADISE CLINICAL STUDY, SUBJECT ID: (B)(6). IT WAS REPORTED THAT FOLLOWING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER THE PATIENT DEVELOPED ATYPICAL ATRIAL FLUTTER. APPROXIMATELY 7 MONTHS AFTER THE PROCEDURE THE PATIENT WAS HOSPITALIZED DUE TO ATYPICAL ATRIAL FLUTTER. AN EP STUDY ALONG WITH AN ABLATION PROCEDURE WAS PERFORMED WHILE THE PATIENT WAS HOSPITALIZED. THE ABLATION WAS PERFORMED ON THE 3RD DAY OF HOSPITALIZATION AND THE PATIENT WAS DISCHARGED THAT SAME DAY WITH NO FURTHER COMPLICATIONS. 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 THE PATIENT HAD A REOCCURRENCE OF THE ATYPICAL FLUTTER AND WAS ADMITTED TO THE HOSPITAL FROM ON (B)(6) 2024 TO RECEIVE A CARDIOVERSION. THE ARRYTHMIA WAS IDENTIFIED THROUGH ECG. THIS RECURRENCE IS CONSIDERED RESOLVED WITH THE CARDIOVERSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518776 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI FARAPULSE, INC. 0008021675

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R