BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER

    MDR report key: 6811703 · Received August 22, 2017

    Report

    Report Number
    2182269-2017-00097
    Event Type
    Malfunction
    Date Received
    August 22, 2017
    Date of Event
    August 4, 2017
    Report Date
    November 29, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    PMA / PMN Number
    K140327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION CONCLUDED THAT A TEAR WAS NOTED ON THE HEMOSTASIS SEAL, LOCATED NEAR THE CENTER OF THE SLIT AND EXTENDED ASYMMETRICALLY BETWEEN THE SLIT CENTER POINT AND THE SEAL EDGE. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES AS SUPPORTED BY A REVIEW OF THE DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED LEAKAGE WAS SEAL DAMAGE CONSISTENT WITH COMPONENT INSERTION AND/OR REMOVAL. THE ULTIMUM INTRODUCER SHEATH INSTRUCTIONS FOR USE (IFU) STATES DAMAGE TO THE VALVE ASSEMBLY MAY OCCUR IF THE INNER CATHETER IS WITHDRAWN RAPIDLY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REVEALED THE INITIAL MDR FOR THIS EVENT WAS REPORTED UNDER THE INCORRECT MFR REPORT # AND MANUFACTURING SITE. CORRECTED MANUFACTURING SITE INFORMATION HAS BEEN PROVIDED. THE CORRECT MFR NUMBER IS (B)(4).

    Description of Event or Problem · 1

    THE PATIENT DID NOT EXPERIENCE ANY ADVERSE HEALTH CONSEQUENCES DUE TO THIS EVENT.

    Description of Event or Problem · 1

    WHILE USING A 19F ULTIMUM EV HEMOSTASIS INTRODUCER, THERE WAS A HIGH AMOUNT OF BLOOD COMING OUT OF THE HEMOSTASIS VALVE/SEAL OF THE INTRODUCER. THE SHEATH WAS NOT REPLACED AND WAS USED UNTIL THE END OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PORTICO PROCEDURE WAS BEING PERFORMED, AND DURING THE PROCEDURE A 0.035" GUIDEWIRE, TWO 6F CATHETERS, A 19F PORTICO DELIVERY SYSTEM, AND A BALLOON SMALLER THAN 19F WERE INSERTED INTO THE INTRODUCER. THE AMOUNT OF BLOOD THAT CAME OUT OF THE HEMOSTASIS VALVE DURING THE PROCEDURE WAS NOT MEASURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591687 ULTIMUM EV HEMOSTASIS INTRODUCER WITH TIP MARKER INTRODUCER, CATHETER DYB ST. JUDE MEDICAL C407699 5904905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other