BEUDAMED
    FDA Adverse Event Death Summary report: N

    FARAWAVE NAV

    MDR report key: 22807845 · Received August 14, 2025

    Report

    Report Number
    2124215-2025-56889
    Event Type
    Death
    Date Received
    August 14, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: OUTCOMES ATTRIB TO ADV EVENT - UPDATED. B5: DESCRIBE EVENT OR PROBLEM - UPDATED. H6: PATIENT CODES, IMPACT CODES- UPDATED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. 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.

    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. 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

    DURING AN ATRIAL FIBRILLATION (AF) ABLATION PROCEDURE, A FARAWAVE 2.0 CATHETER WAS SELECTED FOR USE. AFTER GAINING ACCESS TO THE LEFT ATRIUM, THE PHYSICIAN ATTEMPTED TO POSITION THE CATHETER INTO THE LEFT SUPERIOR PULMONARY VEIN. CATHETER PLACEMENT WAS CONFIRMED USING BOTH THE OPAL HDX MAPPING SYSTEM AND FLUOROSCOPY. UPON INITIATING ABLATION, THE FARASTAR GENERATOR DISPLAYED A 301 ERROR. THE PHYSICIAN PROCEEDED TO REPOSITION THE CATHETER; HOWEVER, PRIOR TO REPOSITIONING, THE PATIENTS BLOOD PRESSURE DROPPED TO 50/30. THE PATIENT EXPERIENCED CARDIAC TAMPONADE. AN ECHOCARDIOGRAPHIC ASSESSMENT REVEALED THE PRESENCE OF BLOOD IN THE PERICARDIAL SPACE, INDICATING A POSSIBLE PERFORATION. EMERGENCY CARDIAC SURGERY WAS PERFORMED TO CLOSE THE PERFORATION, AND THE PATIENT WAS HOSPITALIZED. THE DEVICE IS NOT EXPECTED TO BE RETURNED, AS IT WAS DISPOSED OF FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL TWO WEEKS FOLLOWING THE INITIAL EVENT. HOWEVER, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPTIC SHOCK SEVERAL WEEKS LATER AND PASSED AWAY.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION (AF) ABLATION PROCEDURE, A FARAWAVE NAV CATHETER WAS SELECTED FOR USE. AFTER GAINING ACCESS TO THE LEFT ATRIUM, THE PHYSICIAN ATTEMPTED TO POSITION THE CATHETER INTO THE LEFT SUPERIOR PULMONARY VEIN. CATHETER PLACEMENT WAS CONFIRMED USING BOTH THE OPAL HDX MAPPING SYSTEM AND FLUOROSCOPY. UPON INITIATING ABLATION, THE FARASTAR GENERATOR DISPLAYED A 301 ERROR. THE PHYSICIAN PROCEEDED TO REPOSITION THE CATHETER; HOWEVER, PRIOR TO REPOSITIONING, THE PATIENT'S BLOOD PRESSURE DROPPED TO 50/30. THE PATIENT EXPERIENCED CARDIAC TAMPONADE. AN ECHOCARDIOGRAPHIC ASSESSMENT REVEALED THE PRESENCE OF BLOOD IN THE PERICARDIAL SPACE, INDICATING A POSSIBLE PERFORATION. EMERGENCY CARDIAC SURGERY WAS PERFORMED TO CLOSE THE PERFORATION, AND THE PATIENT WAS HOSPITALIZED. THE DEVICE IS NOT EXPECTED TO BE RETURNED, AS IT WAS DISPOSED OF FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557656 FARAWAVE NAV CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| D