BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM

    MDR report key: 19945589 · Received August 8, 2024

    Report

    Report Number
    2124215-2024-49451
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 16, 2024
    Report Date
    October 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    UDI-DI
    00191506043148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: DEVICE CODES- CORRECTED AND TO ACCOUNT FOR A SIGNAL ISSUE AS OPPOSED TO A MAPPING ISSUE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. UPON DEVICE RETURN AND INSPECTION, IT WAS NOTED THAT ONE OF THE SPLINES IN THE DISTAL CAGE WAS STILL INVERTED. A GUIDEWIRE WAS ADVANCED THROUGH THE CATHETER. THE DEVICE WAS DEPLOYED TO BASKET, WHERE INVERSION WAS STILL VISIBLE. THE INVERTED SPLINE WAS SUBSEQUENTLY MANUALLY PUSHED BACK, AND THE CATHETER WAS DEPLOYED TO FULL FLOWER SUCCESSFULLY. HOWEVER, IN FLOWER DEPLOYMENT POOR PLANARITY OF THE SPLINES WAS OBSERVED, AND THE DEVICE FAILED THE PLANARITY TEST. THE DEVICE WAS THEN FUNCTIONALLY TESTED BY CONNECTING THE CATHETER TO A KNOWN GOOD FARAWAVE CABLE AND A KNOWN GOOD FARASTAR CONSOLE. MULTIPLE ABLATIONS WERE PERFORMED SUCCESSFULLY IN BASKET AND FLOWER STATE, AND NO ABNORMALITIES OR ERRORS WERE OBSERVED DURING TESTING. THE SPLINE CAGE OF THE CATHETER WAS EXAMINED ON THE MICROSCOPE TO LOOK FOR ANY POTENTIAL CAUSE FOR SPLINE INVERSION OR POOR PLANARITY. IT WAS OBSERVED THAT SOME SPLINES WERE THINNER THAN NORMAL AND CONSEQUENTLY RESULTED IN A STEEPER TAKEOFF ANGLE AT THE LOCATION OF THE DISTAL THERMAL WELD. WITH A GUIDEWIRE INSERTED INTO THE CATHETER AND THE CATHETER FULLY DEPLOYED TO FLOWER, CONTINUITY TESTING WAS PERFORMED AND THE DEVICE PASSED. ADDITIONAL ELECTRICAL TESTING WAS PERFORMED ON AN ASSOCIATED RESEARCH HYPOTULTRA 7850 TO CHECK FOR AMPERAGE LEAKAGE BETWEEN SPLINES AT 0.5 AND 3 KV, AND THE DEVICE PASSED HIPOT TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FARAWAVE PULSED FIELD ABLATION CATHETER WAS IN THE LEFT ATRIUM AND WAS NOT DISPLAYED ON THE MAPPING SYSTEM CORRECTLY. HOWEVER, THE NON-BOSTON SCIENTIFIC MAPPING CATHETER AND CS CATHETER WERE DISPLAYED CORRECTLY. THE FARAWAVE CATHETER WAS REVERSED OR PORTRAYING BACKWARDS. ALL CABLES, CONNECTIONS WERE CHECKED, AND THE CATHETER CONNECTION CABLE WAS REPLACED BUT THE ISSUE REMAINED. SUBSEQUENTLY, THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FARAWAVE PULSED FIELD ABLATION CATHETER WAS IN THE LEFT ATRIUM AND WAS NOT DISPLAYED ON THE MAPPING SYSTEM CORRECTLY. HOWEVER, THE NON-BOSTON SCIENTIFIC MAPPING CATHETER AND CS CATHETER WERE DISPLAYED CORRECTLY. THE FARAWAVE CATHETER WAS REVERSED OR PORTRAYING BACKWARDS. ALL CABLES, CONNECTIONS WERE CHECKED, AND THE CATHETER CONNECTION CABLE WAS REPLACED BUT THE ISSUE REMAINED. SUBSEQUENTLY, THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER WAS RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE, THE FARAWAVE PULSED FIELD ABLATION CATHETER WAS IN THE LEFT ATRIUM AND WAS NOT DISPLAYED ON THE MAPPING SYSTEM CORRECTLY. HOWEVER, THE NON-BOSTON SCIENTIFIC MAPPING CATHETER AND CS CATHETER WERE DISPLAYED CORRECTLY. THE FARAWAVE CATHETER WAS REVERSED OR PORTRAYING BACKWARDS. ALL CABLES, CONNECTIONS WERE CHECKED, AND THE CATHETER CONNECTION CABLE WAS REPLACED BUT THE ISSUE REMAINED. SUBSEQUENTLY, THE CATHETER WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS. THE CATHETER WAS RECEIVED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1573413 FARAWAVE PULSED FIELD ABLATION CATHETER, 31MM CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0034176503 00191506043148

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown