BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLAT ION CATHETER, 31MM

    MDR report key: 19768632 · Received July 18, 2024

    Report

    Report Number
    2124215-2024-42807
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 1, 2024
    Report Date
    October 29, 2024
    Manufacturer
    FARAPULSE, INC.
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 0

    UPON DEVICE RETURN AND INSPECTION, IT WAS OBSERVED THAT THE FLUSH LINE CONNECTOR WAS DETACHED FROM THE CATHETER. ADDITIONALLY, IMAGES OF THE DEVICE WERE PROVIDED FROM THE PROCEDURE THAT SHOWED THE DETACHED FLUSH PORT. THE REPORTED EVENT WAS CONFIRMED THE REPORTED LUER DETACHMENT THROUGH RETURNED PRODUCT TESTING. ANALYSIS REVEALED THE LUER AND STRAIN RELIEF WAS DETACHED FROM THE CATHETER FLUSH LINE. INVESTIGATION CONFIRMED THAT THE CATHETER PASSED ALL PASSED ALL TESTING AND SPECIFICATION REQUIREMENTS THROUGHOUT THE MANUFACTURING PROCESS PRIOR TO DISTRIBUTION. IMPROVEMENTS HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO STRENGTHEN THE ADHESIVE BONDING BETWEEN THE STRAIN RELIEF AND FLUSH LUER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER THE PORT OF THE FLUSHING LINE DETACHED. THE CATHETER WAS REPLACED WITH ANOTHER FARAWAVE PFA CATHETER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION FOR A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER THE PORT OF THE FLUSHING LINE DETACHED. THE CATHETER WAS REPLACED WITH ANOTHER FARAWAVE PFA CATHETER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. THE CATHETER HAS BEEN RECEIVED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359649 FARAWAVE PULSED FIELD ABLAT ION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI FARAPULSE, INC. 0034054367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown