BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FARAWAVE NAV

    MDR report key: 24646934 · Received March 20, 2026

    Report

    Report Number
    2124215-2026-15436
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043193
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. 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.

    Description of Event or Problem · 0

    A FARAWAVE NAV CATHETER WAS USED DURING A FARAPULSE ABLATION ON (B)(6) 2026. PULMONARY VEIN ISOLATION (PVI) WAS COMPLETED FIRST. BECAUSE ATRIAL FIBRILLATION PERSISTED AFTER DIRECT CURRENT CARDIOVERSION, THE PHYSICIAN PROCEEDED WITH POSTERIOR WALL ISOLATION. FOLLOWING COMPLETION OF POSTERIOR WALL ISOLATION (PWI), CARDIOVERSION WAS REPEATED AND SUCCESSFULLY RESTORED SINUS RHYTHM, AND THE PROCEDURE CONCLUDED. IN TOTAL, 56 APPLICATIONS WERE DELIVERED FOR PVI AND 19 FOR PWI, WITH AN OVERALL PROCEDURE TIME OF 180 MINUTES. ON (B)(6) 2026, THE PATIENT DEVELOPED NEW ONSET DOUBLE VISION. A CEREBRAL INFARCTION WAS SUSPECTED, AND TREATMENT WAS INITIATED. THE ATTENDING PHYSICIAN NOTED THAT PUBLISHED LITERATURE INDICATES THAT POSTERIOR WALL ABLATION WITH FARAPULSE MAY BE ASSOCIATED WITH THROMBUS FORMATION OR ENDOTHELIAL INJURY, WHICH COULD EMBOLIZE AND RESULT IN CEREBRAL INFARCTION. BASED ON THE TIMING OF SYMPTOM ONSET, THE PHYSICIAN BELIEVES A THROMBUS MAY HAVE EMBOLIZED DURING PWI, LEADING TO THE PATIENT CEREBRAL EVENT. THE PATIENT RECEIVED DRUG ADMINISTRATION (EDARAVONE) AND REMAINED HOSPITALIZED FOR APPROXIMATELY ONE ADDITIONAL WEEK. DOUBLE VISION APPEARS TO BE ONGOING. ALTHOUGH MAGNETIC RESONANCE IMAGING DID NOT SHOW FINDINGS CORRESPONDING TO THE VISUAL SYMPTOMS, THE PHYSICIAN SUSPECTS A POSSIBLE ASSOCIATION WITH THE PFA PROCEDURE. THE DEVICE IS NOT EXPECTED TO BE RETURN DUE TO DISPOSAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15498 FARAWAVE NAV SEE H11 QZI BOSTON SCIENTIFIC CORPORATION 0037760860 00191506043193

    Patients

    Seq Age Sex Outcome Treatment
    1