BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FARADRIVE STEERABLE SHEATH CLEAR

    MDR report key: 20045716 · Received August 23, 2024

    Report

    Report Number
    2124215-2024-52019
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    June 18, 2024
    Report Date
    August 22, 2024
    Manufacturer
    FARAPULSE, INC.
    Product Code
    DRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. E1: INITIAL REPORTER PHONE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT THE BEGINNING OF THE PULMONARY VEIN ISOLATION PROCEDURE, THE FARADRIVE STEERABLE SHEATH EXHIBITED AN AIR LEAK. AFTER THE SHEATH WAS ASPIRATED, A LEAK WAS REVEALED. ADDITIONALLY, THERE WERE NO ABNORMALITIES OBSERVED DURING PREPARATION WITH THIS SHEATH AND NO DAMAGED TO THE LUER WAS OBSERVED. AT THE TIME OF THE EVENT, THE DILATOR AND GUIDEWIRE WERE INSIDE THE SHEATH. SUBSEQUENTLY, THE SHEATH WAS REPLACED, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS. THE SHEATH IS EXPECTED TO RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581696 FARADRIVE STEERABLE SHEATH CLEAR VASCULAR GUIDE-CATHETER, SINGLE-USE DRA FARAPULSE, INC. CL12504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown