BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATINUM PLUS GUIDEWIRE

    MDR report key: 1368269 · Received April 22, 2009

    Report

    Report Number
    2134265-2009-01743
    Event Type
    Injury
    Date Received
    April 22, 2009
    Date of Event
    February 24, 2009
    Report Date
    March 24, 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 "VERY CALCIFIED" TARGET LESION WAS IN THE FEMORAL ARTERY. THE PHYSICIAN ATTEMPTED TO ADVANCE A PLATINUM PLUS-3 018/180 GUIDE WIRE BUT WAS UNABLE TO CROSS THE TARGET LESION. THE PHYSICIAN DECIDED TO "CHANGE THE GUIDE WIRE". AN UNSPECIFIED ENTRAPMENT AND A GUIDE WIRE "FRACTURE" AT THE DISTAL END ALSO OCCURRED. AS THE WIRE WAS BEING PULLED BACK "IT BECAME ALWAYS LONGER AND LONGER (ABOUT 25 INCH)". THE WHOLE WIRE WAS ABLE TO BE REMOVED WITH NO FRAGMENTS LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATINUM PLUS GUIDEWIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC NA 12235315

    Patients

    Seq Age Sex Outcome Treatment
    1 Other