BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE

    MDR report key: 23782608 · Received December 11, 2025

    Report

    Report Number
    2124215-2025-90448
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 10, 2025
    Report Date
    December 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043216
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2A: COMMON DEVICE NAME: PERCUTANEOUS CARDIAC ABLATION CATHETER FOR TREATMENT OF ATRIAL FIBRILLATION WITH IRREVERSIBLE ELECTROPORATION; REPORTED HERE AS THE COMMON DEVICE NAME EXCEEDED THE CHARACTER LIMIT FOR DESIGNATED FIELD. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS NOT AVAILABLE BECAUSE <<INSERT REASON (DEVICE WAS DISCARDED, ETC.)>>. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION. 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 A FEW WEEKS FOLLOWING AN ABLATION PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION (A FIB) BY USING THE FARAWAVE ABLATION CATHETER, THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT FOR A STROKE. THE PATIENT WAS GIVEN UNKNOWN TREATMENT FROM THAT POINT ON AND IS EXPECTED TO FULLY RECOVER. THE DEVICE WILL NOT BE RETURNED AS IT HAS ALREADY BEEN DISPOSED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2626642 FARAWAVE No Match QZI BOSTON SCIENTIFIC CORPORATION 00191506043216

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H