BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRA JAGWIRE GUIDEWIRE

    MDR report key: 1220288 · Received November 3, 2008

    Report

    Report Number
    3005099803-2008-05916
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    EZB
    PMA / PMN Number
    K022059
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, GUIDE WIRE REMOVAL DIFFICULTY OCCURRED. WHILE ATTEMPTING TO EXCHANGE THE CANNULA, THE HYDRA-JAG/ .035/450CM/AGN GUIDE WIRE BECAME STUCK INSIDE THE CANNULA HUB AND THE JACKET OF THE GUIDE WIRE BECAME DEFORMED. WHEN THE GUIDE WIRE WAS REMOVED, THE JACKET OF THE GUIDE WIRE WAS PEELED AND THE CORE WIRE WAS EXPOSED. THE PEELED PORTION OF THE GUIDE WIRE REMAINED INSIDE THE CANNULA. NO PORTION OF THE PEELED JACKET WAS INSIDE THE PT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PT COMPLICATIONS OCCURRED. PT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRA JAGWIRE GUIDEWIRE EZB BOSTON SCIENTIFIC 5605 11905406

    Patients

    Seq Age Sex Outcome Treatment
    1