BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1893961 · Received November 9, 2010

    Report

    Report Number
    2939204-2010-01046
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    DQX
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K022357. CONCLUSION: OTHER FOR ANTICIPATED PROCEDURAL COMPLICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR WAS PERFORMED AND FOUND THE DEVICE MET ALL REQUIRED SPECIFICATION UPON ITS RELEASE. THE DEVICE REMAINS IMPLANTED, SO, WAS NOT AVAILABLE FOR EVALUATION. FROM THE INFORMATION PROVIDED THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. VASOSPASM IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND IS LISTED AS SUCH IN THE DIRECTIONS FOR USE. THEREFORE IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A PERSISTANT VASOSPASM IN THE ASCENDING POSTERIOR FRONTAL/PARIETAL BRANCH OF THE LEFT MIDDLE CEREBRAL ARTERY IN THE LOCATION OF THE GUIDEWIRE DURING STENT PLACEMENT IN THE LEFT INTERNAL CAROTID ARTERY (ICA). THE VASOSPASM RESOLVED ON ITS OWN. THERE WAS NO IMPACT OR CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - MIAMI UNK532

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other 5000 UNITS HEPARIN| NEURON CATHETER (PENUMBRA)| GATEWAY BALLOON CATHETER (BOSTON SCIENTIFIC)| WINGSPAN STENT SYSTEM (BOSTON SCIENTIFIC)