BEUDAMED
    FDA Adverse Event Summary report: N

    HI-TORQUE WHISPER EXTRA SUPPORT GUIDE WIRE

    MDR report key: 2231416 · Received August 26, 2011

    Report

    Report Number
    2231416
    Date Received
    August 26, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQX
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    DURING A PERIPHERAL PROCEDURE IN THE CARDIAC CATHETERIZATION LAB WHILE WIRING THE POPLITEAL ARTERY, THE TIP OF THE WHISPER EXTRA SUPPORT WIRE BROKE FREE IN THE POPLITEAL ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP USING A 4MM MICROSNARE. THERE WERE NO COMPLICATIONS OR HARM TO THE PATIENT. THE PATIENT WAS DISCHARGED AS SCHEDULED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER EXTRA SUPPORT GUIDE WIRE HI-TORQUE WHISPER EXTRA SUPPORT (GUIDE WIRE) 0.014" 300CM DQX ABBOTT VASCULAR * 1052601

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR