BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL4¿, 63 CM LENGTH, 8F

    MDR report key: 20914474 · Received December 12, 2024

    Report

    Report Number
    3005334138-2024-00538
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    UDI-DI
    05414734205702
    PMA / PMN Number
    K052644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF AN EXPIRED DEVICE BEING USED WAS REPORTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL4¿, 63 CM LENGTH, 8F BATCH NUMBER 8112327 EXPIRED ON 31 JUL 2024 WHICH WAS PRIOR TO THE REPORTED EVENT DATE OF 25 NOV 2024. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED, INCLUDING VERIFICATION OF THE EXPIRATION DATE LISTED ON THE PRODUCT LABEL. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE CAUSE OF THE USE OF EXPIRED PRODUCT IS CONSISTENT WITH USER ERROR.

    Description of Event or Problem · 0

    DURING THE PROCEDURE, IT WAS NOTED THAT AN INTRODUCER THAT WAS EXPIRED WAS USED IN A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147156 SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL4¿, 63 CM LENGTH, 8F Introducer, catheter DYB ST. JUDE MEDICAL 407446 8112327 05414734205702

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male