BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 19967333 · Received August 12, 2024

    Report

    Report Number
    2124215-2024-50045
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    August 7, 2024
    Report Date
    December 30, 2024
    Manufacturer
    FARAPULSE, INC.
    Product Code
    DRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    UPON RECIPIENT AT THE BOSTON SCIENTIFIC'S POST MARKET LABORATORY THE SHEATH WAS FIRST VISUALLY INSPECTED WHICH FOUND NO ABNORMALITIES. WHEN THEY NEXT FUNCTIONALLY TESTED THE SHEATH, THEY FOUND THE KNOB COULD ROTATE BUT DID NOT ENGAGE WITH THE STEERING MECHANISM. NEXT, THE SHEATH WAS EXAMINED UNDER X-RAY AND INVESTIGATORS SAW A LOOSE PULL WIRE IN THE SHEATH. WHEN THEY DISSECTED THE SHAFT, THEY FOUND THE END OF THE PULL WIRE WAS NOT CRIMPED AND HAD NOT FASTENED TO THE STEERING MECHANISM. THE STEERING FAILURE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE COMPONENT FAILURE. THE LOOSE PULL WRE WOULD CAUSE THE STEERING OF THE SHEET TO BECOME IMPOSSIBLE.

    Description of Event or Problem · 0

    THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT THE SHEATH CONTROL KNOB WAS DIFFICULT TO TURN AND EVENTUALLY BROKE. THE PROCEDURE WAS CANCELLED. DURING A PULSE FIELD ABLATION (PFA) PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION A FARADRIVE STEERABLE SHEATH CLEAR WAS USED. AT THE BEGINNING OF THE CASE THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM (LA) AND IT WAS FOUND THAT THE CONTROL KNOB WAS DIFFICULT TO TURN AND SEEMED BLOCKED FROM TURNING. THE SHEATH WAS MOVED BACK INTO THE RIGHT ATRIUM (RA) AND THE CONTROL KNOW WORKED WELL. WHEN THE SHEATH WAS MOVED BACK TO THE LA, BUT AFTER A FEW MANIPULATIONS A NOISE WAS HEARD. IT WAS THEN FOUND THAT THE CONTROL KNOB WAS BROKEN. THE PROCEDURE WAS CANCELLED DUE TO TIME CONSTRAINTS AND THE DIFFICULTIES HANDLING THE SHEATH IN THE LA. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHEATH CONTROL KNOB WAS DIFFICULT TO TURN AND EVENTUALLY BROKE. THE PROCEDURE WAS CANCELLED. DURING A PULSE FIELD ABLATION (PFA) PULMONARY VEIN ISOLATION (PVI) PROCEDURE TO TREAT ATRIAL FIBRILLATION A FARADRIVE STEERABLE SHEATH CLEAR WAS USED. AT THE BEGINNING OF THE CASE THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM (LA) AND IT WAS FOUND THAT THE CONTROL KNOB WAS DIFFICULT TO TURN AND SEEMED BLOCKED FROM TURNING. THE SHEATH WAS MOVED BACK INTO THE RIGHT ATRIUM (RA) AND THE CONTROL KNOW WORKED WELL. WHEN THE SHEATH WAS MOVED BACK TO THE LA, BUT AFTER A FEW MANIPULATIONS A NOISE WAS HEARD. IT WAS THEN FOUND THAT THE CONTROL KNOB WAS BROKEN. THE PROCEDURE WAS CANCELLED DUE TO TIME CONSTRAINTS AND THE DIFFICULTIES HANDLING THE SHEATH IN THE LA. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2463019 FARADRIVE STEERABLE SHEATH CLEAR CATHETER, STEERABLE DRA FARAPULSE, INC. CL12888

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown