BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM

    MDR report key: 21068394 · Received January 3, 2025

    Report

    Report Number
    3005334138-2025-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2025
    Date of Event
    December 10, 2024
    Report Date
    March 24, 2025
    Manufacturer
    ST. JUDE 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

    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

    UDI INFORMATION (D4) AND 510K (G3) ARE NOT PROVIDED WITHIN THIS REPORT AS THIS PRODUCT (MODEL G407371) IS AN OUS CONFIGURATION NOT AVAILABLE IN THE US AND IS THEREFORE NOT REFERENCED IN THE GUDID DATABASE.

    Additional Manufacturer Narrative · 0

    AN EVENT OF AIR ASPIRATION WAS REPORTED. 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. THE IFU STATES: DO NOT REMOVE DILATOR OR CATHETER RAPIDLY. DAMAGE TO THE VALVE MAY OCCUR, POTENTIALLY COMPROMISING HEMOSTASIS.

    Description of Event or Problem · 0

    DURING A PULMONARY VEIN ISOLATION PROCEDURE FOR ATRIAL FIBRILLATION, WHEN REMOVING AIR IN THE SHEATH USING A SYRINGE, AIR WAS ASPIRATED FROM THE VALVE. THERE WAS NO AIR MOVEMENT INTO THE PATIENT¿S BODY. IN ADDITION, THERE WAS NO PHYSICAL DAMAGE TO THE SHEATH OR PACKAGING. 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
    640037 BRAIDED SWARTZ¿ INTRODUCER, SL0¿. 8F, 63CM INTRODUCER, CATHETER DYB ST. JUDE MEDICAL G407371 10451450

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male