BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILITY HYDROPHILIC STEERABLE GUIDEWIRES

    MDR report key: 896396 · Received August 13, 2007

    Report

    Report Number
    1058196-2007-00125
    Event Type
    Injury
    Date Received
    August 13, 2007
    Date of Event
    July 5, 2007
    Report Date
    July 18, 2007
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    DQX
    PMA / PMN Number
    K001033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT SUFFERED A (TIA) TRANSIENT ISCHEMIC ATTACK LIKE SYMPTOMS AND WAS TAKEN TO THE HOSPITAL FOR EVALUATION. THE PATIENT WAS DIAGNOSED WITH A HIGH-GRADE STENOSIS IN LEFT MIDDLE CEREBRAL ARTERY, AND UNDERWENT STENTING OF THE LEFT CEREBRAL ARTERY. DURING THE PROCEDURE, THE AGILITY GUIDEWIRE PERFORATED THE VESSEL DISTAL TO THE STENT PLACEMENT. THE PATIENT WAS TAKEN TO CT, AND A SUBARACHNOID HEMORRHAGE WAS NOTED ON THE CT SCAN. THE PATIENT WAS TRANSFERRED FROM INTERVENTIONAL RADIOLOGY TO CCJ. A DAY AFTER THE EVENT, AT THE REQUEST OF THE FAMILY, MEDICAL CARE WAS STOPPED, AND THE PATIENT EXPIRED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, BUT TO DATE, NO INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILITY HYDROPHILIC STEERABLE GUIDEWIRES CES GUIDEWIRES (DQX) DQX CORDIS NEUROVASCULAR, INC. NA 13172848

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| L| R