BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, MEDIUM CURL, 8.5F

    MDR report key: 22293019 · Received June 19, 2025

    Report

    Report Number
    3008452825-2025-00292
    Event Type
    Malfunction
    Date Received
    June 19, 2025
    Date of Event
    June 17, 2025
    Report Date
    July 18, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DYB
    UDI-DI
    05414734206129
    PMA / PMN Number
    K061363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 8.5F AGILIS STEERABLE INTRODUCER SHEATH WAS RECEIVED FOR EVALUATION. FUNCTIONAL TESTING DETERMINED A LEAK WAS NOTED IN THE HEMOSTASIS VALVE. THE CAP WAS REMOVED FROM THE HEMOSTASIS HUB AND THE HEMOSTASIS SEALS WERE MICROSCOPICALLY INSPECTED. TEARING, RESULTING IN A HOLE, WAS NOTED IN THE PROXIMAL AND DISTAL SEALS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE TORN SEALS AND SUBSEQUENT LEAK REMAINS UNKNOWN. THE IFU STATES: DO NOT REMOVE DILATOR OR CATHETER RAPIDLY. DAMAGE TO THE VALVE MAY OCCUR, POTENTIALLY COMPROMISING HEMOSTASIS.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE, AN AIR LEAK WAS NOTED IN THE SHEATH. THE DILATOR WAS INSERTED INTO THE SHEATH AND PUNCTURE WAS PERFORMED. THE INTRODUCER WAS INSERTED INTO THE LEFT ATRIUM, AND WHEN ATTEMPTING TO INSERT THE HDG CATHETER, AIR WAS ASPIRATED. THE INTRODUCER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788164 AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, MEDIUM CURL, 8.5F INTRODUCER, CATHETER DYB ABBOTT MEDICAL G408319 10695305 05414734206129

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown