BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWARTZ BRAIDED TRANS. GUIDING INT., 8F, SLO

    MDR report key: 2971135 · Received February 1, 2013

    Report

    Report Number
    3005188751-2013-00016
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K052644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR ANALYSIS. WHEN OUR INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SWARTZ BRAIDED TRANSSEPTAL INTRODUCER AND DILATOR ASSEMBLY WAS ADVANCED OVER THE GUIDEWIRE AND THE SIDE PORT WAS FLUSHED. THE PHYSICIAN THEN NOTED BLOOD LEAKING FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. THERE WERE NO CONSEQUENCES TO THE PATIENT. FURTHER INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45358 SWARTZ BRAIDED TRANS. GUIDING INT., 8F, SLO TRANSSEPTAL CATHETER INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 407449 3792694

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR