BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARAWAVE

    MDR report key: 20722926 · Received November 19, 2024

    Report

    Report Number
    2124215-2024-72621
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    November 6, 2024
    Report Date
    February 13, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    QZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR.: UPON RECEIPT AT BOSTON SCIENTIFIC'S POST MARKET LABORATORY, IT WAS NOTED THE CATHETER WAS RETURNED WITH THE GUIDEWIRE STILL INSERTED THROUGH THE DEVICE. VISUAL INSPECTION OF THE DEVICE NOTED NO ABNORMALITIES. AN ATTEMPT TO WITHDRAW THE INSERTED GUIDEWIRE WAS UNSUCCESSFUL DURING FUNCTIONAL TESTING. DISSECTION OF THE CATHETER REVEALED KINKING OF THE GUIDEWIRE LUMEN JUST OUTSIDE THE INNER HYPOTUBE. IT WAS REPORTED THAT POSTERIOR WALL ISOLATION (PWI) WAS PERFORMED WITHOUT THE GUIDEWIRE WHILE IN FLOWER CONFIGURATION. IT IS LIKELY THAT THE KINK IN THE GUIDEWIRE LUMEN OCCURRED WHEN THE USER DEPLOYED AND UNDEPLOYED THE CATHETER WITHOUT A GUIDEWIRE INSERTED. THE REPORTED STUCK GUIDEWIRE EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A STUCK GUIDEWIRE OCCURRED. DURING AN PULSED FIELD ABLATION (PFA) PROCEDURE, A FARAWAVE PFA CATHETER WAS SELECTED FOR USE. WITH THE CATHETER IN FLOWER CONFIGURATION, THE GUIDEWIRE COULD NOT RETRACT OR ADVANCE IN THE CATHETER. THE GUIDEWIRE WOULD ONLY RETRACT AND ADVANCE WHILE IN THE CHAMBER WITH THE CATHETER IN THE BASKET CONFIGURATION. THERE WERE NO ISSUES NOTED PRIOR TO THE PROCEDURE DURING TESTING. ONLY POSTERIOR WALL ISOLATION (PWI) WAS COMPLETED FOLLOWING THE STUCK GUIDEWIRE. PWI WAS COMPLETED WITHOUT THE GUIDEWIRE WHILE IN FLOWER CONFIGURATION AFTER RETRACTING THE GUIDEWIRE WHILE IN BASKET CONFIGURATION. USE OF THE DEVICE TO PERFORM PWI CONSTITUTED OFF-LABEL USE, AS THE CATHETER IS ONLY INDICATED TO PERFORM PULMONARY VEIN ISOLATION PER THE INSTRUCTIONS FOR USE (IFU). TO LIMIT AN EXCHANGE, THE ORIGINAL CATHETER WAS USED TO COMPLETE THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CATHETER WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A STUCK GUIDEWIRE OCCURRED. DURING AN PULSED FIELD ABLATION (PFA) PROCEDURE, A FARAWAVE PFA CATHETER WAS SELECTED FOR USE. WITH THE CATHETER IN FLOWER CONFIGURATION, THE GUIDEWIRE COULD NOT RETRACT OR ADVANCE IN THE CATHETER. THE GUIDEWIRE WOULD ONLY RETRACT AND ADVANCE WHILE IN THE CHAMBER WITH THE CATHETER IN THE BASKET CONFIGURATION. THERE WERE NO ISSUES NOTED PRIOR TO THE PROCEDURE DURING TESTING. ONLY POSTERIOR WALL ISOLATION (PWI) WAS COMPLETED FOLLOWING THE STUCK GUIDEWIRE. PWI WAS COMPLETED WITHOUT THE GUIDEWIRE WHILE IN FLOWER CONFIGURATION AFTER RETRACTING THE GUIDEWIRE WHILE IN BASKET CONFIGURATION. USE OF THE DEVICE TO PERFORM PWI CONSTITUTED OFF-LABEL USE, AS THE CATHETER IS ONLY INDICATED TO PERFORM PULMONARY VEIN ISOLATION PER THE INSTRUCTIONS FOR USE (IFU). TO LIMIT AN EXCHANGE, THE ORIGINAL CATHETER WAS USED TO COMPLETE THIS PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THE CATHETER IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1335285 FARAWAVE CARDIAC IRREVERSIBLE ELECTROPORATION SYSTEM CATHETER QZI BOSTON SCIENTIFIC CORPORATION 0035090877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown