BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿

    MDR report key: 19002528 · Received March 29, 2024

    Report

    Report Number
    2182269-2024-00007
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    January 30, 2024
    Report Date
    March 29, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DYB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 13F AGILIS STEERABLE INTRODUCER SHEATH AND DILATOR WERE RECEIVED FOR EVALUATION. FUNCTIONAL TESTING CONFIRMED AN AIR LEAK IN THE HEMOSTASIS VALVE. THE CAP WAS REMOVED FROM THE HEMOSTASIS HUB AND MICROSCOPIC INSPECTION REVEALED TEARING IN THE DISTAL FACE OF THE SEAL. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE TORN SEAL AND SUBSEQUENT LEAK REMAINS UNKNOWN. THIS REPORT IS BEING FILED ON A PRE-MARKET CLINICAL PRODUCT, 13F AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿, THAT HAS A SIMILAR APPROVED/CLEARED PRODUCT DISTRIBUTED IN THE U.S., 8.5F AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ (510(K)# K061363).

    Description of Event or Problem · 0

    THIS REPORT IS TO ADVISE OF AN AIR LEAK NOTED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2584519 AGILIS¿NXT STEERABLE INTRODUCER DUAL-REACH¿ Introducer, catheter DYB ST. JUDE MEDICAL, INC. I-V2-MED 10028683

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown