BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21002030 · Received December 23, 2024

    Report

    Report Number
    3008452825-2024-00740
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 2, 2024
    Report Date
    March 25, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K081645
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: G3, H2, H6. A FOLLOW UP FINAL IS BEING SUBMITTED AS THE C CODE WAS UPDATED TO MECHANICAL PROBLEM IDENTIFIED C07 : STRESS PROBLEM IDENTIFIED C0706 : FRACTURE PROBLEM C070603 WITH INTERNAL CLARIFYING CODE EP - TORN/RIPPED COMPONENT C070603-061.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6, H11. AN EVENT OF A LEAK WAS REPORTED. THE SHEATH PASSED PRESSURE AND ASPIRATION LEAK TESTING WITH NO ANOMALIES OBSERVED. 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 DAMAGED SEALS 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 A VENTRICULAR TACHYCARDIA PROCEDURE, WHEN THE SHEATH WAS INSERTED INTO THE LEFT ATRIUM AND THE DILATOR WAS REMOVED BEFORE CATHETER INSERTION, BLOOD LEAKED FROM THE HEMOSTASIS VALVE. THE SHEATH 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
    2627173 AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 71 CM SHEATH, LARGE CURL, 8.5F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL G408324 10441329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown