BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SL SERIES, SL0¿ 10F

    MDR report key: 24571262 · Received March 11, 2026

    Report

    Report Number
    3005334138-2026-00126
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DYB
    UDI-DI
    05414734203562
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H2, H3, H6, H11. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    DURING THE ATRIAL FIBRILLATION PROCEDURE, BLOOD LEAKED FROM THE HEMOSTASIS VALVE OF THE SHEATH. AFTER THE SHEATH WAS INSERTED INTO THE RIGHT ATRIUM, A NON-ABBOTT CATHETER (JLL, BEAT) WAS ADVANCED THROUGH THE SHEATH AND BLOOD LEAKAGE WAS NOTED 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
    455907 FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER SL SERIES, SL0¿ 10F INTRODUCER, CATHETER DYB ABBOTT MEDICAL 406968 10806231 05414734203562

    Patients

    Seq Age Sex Outcome Treatment
    1