BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 19924755 · Received August 6, 2024

    Report

    Report Number
    2124215-2024-48070
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT A RESPONSE HAS NOT BEEN RECEIVED YET. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DAY FOLLOWING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE CATHETER THE PATIENT PRESENTED WITH CHEST PAIN AND A SMALL PERICARDIAL EFFUSION. THE PROCEDURE HAD BEEN COMPLETED SUCCESSFULLY AND THE NEXT DAY THE PATIENT REPORTED EXPERIENCING CHEST PAIN. A SMALL PERICARDIAL EFFUSION WAS IDENTIFIED, AND THE PATIENT WAS DIAGNOSED WITH PERICARDITIS. MEDICATION WAS PRESCRIBED AND THE CONDITION IS CONSIDERED ONGOING. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553023 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention