BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM CURL, 8.5 F

    MDR report key: 16496736 · Received March 7, 2023

    Report

    Report Number
    3008452825-2023-00090
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 24, 2023
    Report Date
    April 3, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    UDI-DI
    05414734206105
    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

    ADDITIONAL INFORMATION: D9, G3, G6, H2, H3, H6. ONE 8.5F AGILIS STEERABLE INTRODUCER SHEATH WAS RECEIVED FOR EVALUATION. THE DILATOR WAS ALSO RECEIVED. FUNCTIONAL TESTING CONFIRMED A FLUID LEAK 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.

    Description of Event or Problem · 0

    DURING THE ATRIAL FIBRILLATION PROCEDURE, A BLOOD LEAK WAS NOTED FROM THE HEMOSTASIS VALVE PRIOR TO INSERTING THE CATHETER AND SEPTAL PUNCTURE NEEDLE INTO THE SHEATH. THE INTRODUCER WAS REPLACED TO A NON-ABBOTT DEVICE (JLL MANUFACTURED VIZIGO) AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL VENIPUNCTURE WAS PERFORMED FOR SHEATH REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63623 AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, MEDIUM CURL, 8.5 F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 408310 8304216 05414734206105

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown