BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM PLUS GUIDEWIRE

    MDR report key: 1388111 · Received May 19, 2009

    Report

    Report Number
    2134265-2009-02301
    Event Type
    Injury
    Date Received
    May 19, 2009
    Date of Event
    April 2, 2009
    Report Date
    April 20, 2009
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K935997
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS ANGIOPLASTY (PTA) PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. THE UNSPECIFIED TARGET LESION WAS IN THE "POPLITEA" ARTERY. THE PHYSICIAN REPORTEDLY "USED THE GUIDE WIRE LIKE A BURR", "TO DRILL THROUGH THE OCCLUSION" WITH A PLATINUM PLUS-3 018/180 GUIDE WIRE; HOWEVER, THE PHYSICIAN WAS UNABLE TO CROSS THE TARGET LESION. THE PHYSICIAN DECIDED TO "CHANGE THE GUIDE WIRE". AN ENTRAPMENT AND A GUIDE WIRE FRACTURE OCCURRED. THE DEVICE WAS ABLE TO BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S CURRENT CONDITION WAS LISTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other