BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZINGER GUIDEWIRE

    MDR report key: 6180847 · Received December 16, 2016

    Report

    Report Number
    6180847
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Date of Event
    November 11, 2016
    Report Date
    November 23, 2016
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAVING A PERCUTANEOUS CORONARY INTERVENTION (PCI) OF BIFURCATING OTITIS MEDIA AND MID CIRCUMFLEX LESIONS FOR NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI). ZINGER WIRE WAS PLACED IN OM AND A PROWATER WIRE WAS PLACED IN MID CIRCUMFLEX THROUGH A6FR X 3.5 GUIDE CATHETER. WHILE ATTEMPTING TO REMOVE THE WIRE FROM THE OM VESSEL THE TIP BROKE OFF AND REMAINED IN OM VESSEL. TIP WAS RETRIEVED USING AN AMPLATZ MICROSNARE GOOSE NECK. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH BOTH VESSELS STENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831796 ZINGER GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC VASCULAR G15A05469

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR CARDIAC DRUGS