BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 19805353 · Received July 23, 2024

    Report

    Report Number
    2124215-2024-44709
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 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

    B5: DESCRIBE EVENT OR PROBLEM - UPDATED AND CORRECTED WITH ADDITIONAL NARRATIVE SURROUNDING THE EVENT. DEVICE EVALUATED BY MFR.: 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 OUTER VALVE. ADDITIONALLY, MICROSCOPIC INSPECTION REVEALED A TEAR IN THE FLUSH LUMEN CLOSE TO THE VALVE UNDERNEATH THE HANDLE CAP. DEIONIZED WATER WAS INJECTED INTO THE FLUSH PORT, HOWEVER, THIS DID NOT CAUSE THE FLUSH PORT TO LEAK. HOWEVER, PRESSURE AND VACUUM TESTING WERE PERFORMED, AND THE SHEATH EXHIBITED LEAKING (BOTH AIR INGRESS AND FLUID EGRESS) THROUGH THE TEAR ON THE OUTER VALVE.

    Description of Event or Problem · 0

    DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. NO ABNORMALITIES WERE NOTED DURING PREPARATION. IT WAS REPORTED THAT WHILE ASPIRATING WITH A SYRINGE FROM THE SIDE PORT, AIR INGRESS WAS SEEN IN THE SHEATH. AIR GOT IN THE SHEATH AND BUBBLES WERE OBSERVED IN THE FLUSHING LINE AND IN THE ASPIRATION SYRINGE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED.

    Description of Event or Problem · 0

    DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A FARADRIVE STEERABLE SHEATH CLEAR WAS SELECTED FOR USE. NO ABNORMALITIES WERE NOTED DURING PREPARATION. IT WAS REPORTED THAT WHILE ASPIRATING WITH A SYRINGE FROM THE SIDE PORT, AIR INGRESS WAS SEEN IN THE SHEATH. AIR GOT IN THE SHEATH AND BUBBLES WERE OBSERVED IN THE FLUSHING LINE AND IN THE ASPIRATION SYRINGE. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE IS EXPECTED TO BE RETURNED. IT WAS FURTHER REPORTED THAT AIR WAS SEEN AFTER REMOVING THE DILATOR, WITH THE SHEATH IN LEFT ATRIUM. THE FARAWAVE CATHETER AND THE GUIDEWIRE WERE NOT YET INSERTED IN THE SHEATH. NO AIR WAS VISIBLE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2465957 FARADRIVE STEERABLE SHEATH CLEAR VASCULAR GUIDE-CATHETER, SINGLE-USE DRA FARAPULSE, INC. CL12693

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown