BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH¿TRIO INTRODUCER, 10F, ACT

    MDR report key: 23918752 · Received December 29, 2025

    Report

    Report Number
    3005334138-2025-00790
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 5, 2025
    Report Date
    February 13, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DYB
    UDI-DI
    05414734204057
    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, H2, H3, H6, H11. ONE 10F FAST-CATH INTRODUCER SHEATH AND TRIO HEMOSTASIS CAP WAS RECEIVED FOR EVALUATION. THE TRIO HEMOSTASIS CAP SCREWED ONTO THE SHEATH WITH NO ANOMALIES. THE TRIO HEMOSTASIS CAPS INSIDE DIAMETERS WERE WITHIN SPECIFICATIONS AND NO ANOMALIES WERE NOTED WHEN A GUIDEWIRE FROM CURRENT INVENTORY WAS INSERTED. NO VISUAL ANOMALIES WERE NOTED ON THE RETURNED DEVICE. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE CAUSE OF THE REPORTED EVENTS OF THE CONNECTOR PARTS BROKE OFF REMAINS UNKNOWN.

    Description of Event or Problem · 0

    DURING THE ATRIAL FIBRILLATION PROCEDURE, WHEN THE NON-ABBOTT CATHETER (JLL ELECTRODE CATHETER) WAS INSERTED, RESISTANCE WAS MET AND IT COULD NOT BE INSERTED. UPON INSPECTING THE SHEATH, IT WAS NOTED THAT THE CONNECTOR PARTS HAD BROKEN OFF. THERE WAS NO DAMAGE NOTED ON THE NON-ABBOTT CATHETER (JLL ELECTRODE CATHETER). 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
    2196522 FAST-CATH¿TRIO INTRODUCER, 10F, ACT INTRODUCER, CATHETER DYB ABBOTT MEDICAL 406963 10856128 05414734204057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown