BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NITREX® GUIDEWIRE

    MDR report key: 2161364 · Received July 13, 2011

    Report

    Report Number
    2183870-2011-00136
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD A LESION IN THE LEFT RENAL. A 6F SHEATH WAS INSERTED IN RFA. THE NITREX .014 WIRE WAS INSERTED INTO THE RENAL. THE PHYSICIAN PREDIALATED WITH A 4.0 X 20MM BALLOON OVER NITREX WIRE. THE PHYSICIAN THEN INSERTED A 5.0 X 15MM STENT IN RENAL. AFTER DEPLOYMENT OF THE STENT THE PHYSICIAN REMOVED THE BALLOON AND TOOK AN ANGIO. THE PHYSICIAN WAS PLEASED WITH RESULT, AND PULLED THE WIRE BACK INTO THE SHEATH. BEFORE THE WIRE REACHED THE SHEATH THE WIRE GOT STUCK IN THE DISTAL PORTION OF THE STENT. AS THE PHYSICIAN TRIED TO REMOVE THE NITREX WIRE FROM THE STENT, THE GOLD TOP OF THE NITREX WIRE STRAIGHTENED IN THE PATIENT AND FRACTURED IN THE SHEATH. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS TO REMOVE THE WIRE BUT WAS UNSUCCESSFUL. THE PATIENT WENT TO THE OR TO HAVE THE WIRE REMOVED AND A BYPASS ATTACHED THE RENAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NITREX® GUIDEWIRE WIRE, GUIDE, CATHETER DQX EV3 INC. N143001 01425655

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention 4.0X20MM ABBOTT BALLOON| 5.0X15MM BSC EXPRESS STENT