BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 19893197 · Received August 2, 2024

    Report

    Report Number
    2124215-2024-47513
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Date of Event
    July 11, 2024
    Report Date
    October 8, 2024
    Manufacturer
    FARAPULSE, INC.
    Product Code
    DRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCED FARADRIVE STEERABLE SHEATH WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION OF THE DEVICE NOTED NO ABNORMALITIES. MICROSCOPIC INSPECTION OF THE HEMOSTATIC VALVE IDENTIFIED A TEAR IN THE INNER VALVE. PRESSURE AND VACUUM TESTING WERE PERFORMED, AND THE SHEATH EXHIBITED LEAKING (BOTH AIR INGRESS AND FLUID EGRESS) THROUGH THE TEAR ON THE INNER VALVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AIR IN THE SHEATH. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AF), A FARADRIVE STEERABLE SHEATH WAS SELECTED FOR USE. AFTER INTRODUCTION OF THE FARAWAVE INTO THE SHEATH, AIR WAS OBSERVED. THE SHEATH WAS ASPIRATED, BUT THE ISSUE DID NOT RESOLVE. IT WAS CONFIRMED THAT THE SHEATH WAS IN THE MIDDLE OF THE LEFT ATRIUM AND NO VACUUM EFFECT WAS OCCURRING. IT WAS BELIEVED THAT THE VALVE WAS DEFECTIVE. DEVICES THAT HAD BEEN INSIDE THE SHEATH PRIOR TO, AND/OR AT THE TIME, THE AIR WAS OBSERVED INCLUDED THE DILATOR AND THE FARAWAVE. THE IRRIGATION WAS THE SAME SYSTEM AS ALWAYS, THE FLOW RATE WAS 120 ML/H. THERE WERE EXCESSIVE BUBBLES IN ASPIRATION. NO AIR WAS SEEN IN THE PATIENT. THE GUIDEWIRE WAS GOOD POSITION WHEN THE FARAWAVE WAS INSERTED INTO THE SHEATH. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AIR IN THE SHEATH. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AF), A FARADRIVE STEERABLE SHEATH WAS SELECTED FOR USE. AFTER INTRODUCTION OF THE FARAWAVE INTO THE SHEATH, AIR WAS OBSERVED. THERE WAS NO AIR DETECTED WHILE RETRIEVING THE DILATOR DURING PREPARATION. THE SHEATH WAS ASPIRATED, BUT THE ISSUE DID NOT RESOLVE. IT WAS CONFIRMED THAT THE SHEATH WAS IN THE MIDDLE OF THE LEFT ATRIUM AND NO VACUUM EFFECT WAS OCCURRING. IT WAS BELIEVED THAT THE VALVE WAS DEFECTIVE. ONLY THE DILATOR AND FARWAVE HAD BEEN INSIDE THE SHEATH PRIOR TO AND DURING THE TIME THE AIR WAS OBSERVED. THE GUIDEWIRE WAS IN GOOD POSITION WHEN THE CATHETER WAS INSERTED INTO THE SHEATH. THE FLOW RATE FOR THE IRRIGATION WAS 120ML/H. NO AIR WAS SEEN IN THE PATIENT. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741282 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA FARAPULSE, INC. CL12701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown