BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC TORQUE GUIDEWIRE

    MDR report key: 1080634 · Received July 22, 2008

    Report

    Report Number
    2134265-2008-02047
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQX
    PMA / PMN Number
    K935997
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURE, WIRE PEELING OCCURRED. DURING CLINICAL FOLLOW UP OF ANOTHER EVENT WITH GUIDE WIRE PEELING, IT WAS STATED THAT THE OTHER EVENT WAS THE SECOND EVENT. THEREFORE, THIS REPORT IS BEING FILED TO COVER THE INITIAL EVENT, ALTHOUGH NO FURTHER INFORMATION HAS BEEN PROVIDED. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1