BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F

    MDR report key: 21088261 · Received January 6, 2025

    Report

    Report Number
    3005334138-2025-00011
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    December 16, 2024
    Report Date
    March 24, 2025
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    UDI-DI
    05414734205757
    PMA / PMN Number
    K052644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ONE 8.5F SWARTZ BRAIDED INTRODUCER SHEATH WAS RECEIVED FOR EVALUATION. 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.

    Description of Event or Problem · 0

    DURING AN ATRIAL FIBRILLATION PROCEDURE, AIR WAS ASPIRATED WHEN ASPIRATING BLOOD. THE INTRODUCER WAS REPLACED, BUT THE SAME ISSUE OCCURRED. THE INTRODUCER WAS REPLACED AGAIN, AND THE PROCEDURE WAS COMPLETED WITH NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381586 SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL0¿, 63 CM LENGTH, 8.5 F INTRODUCER, CATHETER DYB ST. JUDE MEDICAL 407451 10503834 05414734205757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER