BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAST-CATH HEMO INT SWARTZ SRO, 8F, 60CM

    MDR report key: 2971512 · Received February 4, 2013

    Report

    Report Number
    3005188751-2013-00020
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC. (AF-MINNETONKA)
    Product Code
    DYB
    PMA / PMN Number
    K061015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THIS LOT MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE ROOT CAUSE CLASSIFICATION CANNOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE FAST CATH INTRODUCER/DILATOR ASSEMBLY WAS ADVANCED OVER THE GUIDEWIRE AND THE SIDE PORT WAS FLUSHED. THE PHYSICIAN NOTED BLOOD LEAKING FROM THE HEMOSTASIS VALVE OF THE INTRODUCER. THE INTRODUCER WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47403 FAST-CATH HEMO INT SWARTZ SRO, 8F, 60CM CATHETER INTRODUCER DYB ST. JUDE MEDICAL, INC. (AF-MINNETONKA) 406844 3134740

    Patients

    Seq Age Sex Outcome Treatment
    1