BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE

    MDR report key: 21878209 · Received April 21, 2025

    Report

    Report Number
    2124215-2025-24887
    Event Type
    Death
    Date Received
    April 21, 2025
    Date of Event
    January 30, 2025
    Report Date
    April 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. GOOD FAITH EFFORTS TO OBTAIN THE INFORMATION ARE IN PROGRESS. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) AND OTHER SPECIFIC PRODUCT INFORMATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED IF THE INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A PULSE FIELD ABLATION (PFA) PROCEDURE USING A FARAWAVE PFA CATHETER THE PATIENT PASSED AWAY. THE PROCEDURE WAS COMPLETED ON (B)(6) 2025 AND THE PATIENT PASSED AWAY ON (B)(6) 2025 DUE TO "ACUTE HYPOXIC RESPIRATORY FAILURE, BILATERAL PULMONARY INFILTRATE/ (DIFFUSE ALVEOLAR HEMMORRHAGE) DAH, (NONE-ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION) NSTEMI, PNEUMONIA". FURTHER INFORMATION REGARDING THE TIMELINE LEADING UP TO THE PATIENT'S DEATH WAS NOT PROVIDED BY THE FACILITY. 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
    911538 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death