BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1023797 · Received April 1, 2008

    Report

    Report Number
    9616099-2008-00825
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    K041796
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING ADVANCEMENT OF THE PRECISE SDS THROUGH A 7F SHUTTLE GUIDING CATHETER, THE STENT DEPLOYED WITHIN THE GUIDE. THE GUIDE WAS REMOVED FROM THE PT WITH THE STENT INSIDE IT. AN 8 X 30 PRECISE WAS THEN USED TO SUCCESSFULLY STENT THE LESION IN THE LEFT SUBCLAVIAN ARTERY. THERE WAS NO REPORT OF PT INJURY. AS PER THE QUALRAP, IT IS POSSIBLE THAT THE USER INADVERTENTLY DEPLOYED THE STENT IN THE GUIDE BY ACCIDENT, BUT THIS DOES NOT SEEM LIKELY AS THE ROTATING HEMOSTASIS VALVE WAS SAID TO BE TIGHTENED DOWN DURING ADVANCEMENT. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (FGE) FGE CORDIS DE MEXICO NA 13117890

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 7F SHUTTLE GUIDING CATHETER