BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F

    MDR report key: 22806704 · Received August 14, 2025

    Report

    Report Number
    3005334138-2025-00492
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 14, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED AIR LEAK COULD NOT BE CONCLUSIVELY DETERMINED. UDI INFORMATION (D4) AND 510K (G3) ARE NOT PROVIDED WITHIN THIS REPORT AS THIS PRODUCT (MODEL G407376) IS AN OUS CONFIGURATION NOT AVAILABLE IN THE US AND IS THEREFORE NOT REFERENCED IN THE GUDID DATABASE.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED FROM THE PORT SHORTLY AFTER THE HDG CATHETER WAS INSERTED INTO THE PATIENT'S BODY. 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
    1627833 SWARTZ¿ BRAIDED TRANSSEPTAL INTRODUCER, SL0¿, 8.5 F Introducer, catheter DYB ABBOTT MEDICAL G407376 10736321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown