BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE HYDROPHILIC GUIDEWIRE

    MDR report key: 505778 · Received January 9, 2004

    Report

    Report Number
    2029214-2004-00001
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    November 20, 2003
    Report Date
    December 9, 2003
    Manufacturer
    MICRO THERAPEUTICS, INC.
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PROCEDURE WAS FOR THE EMBOLIZATION OF A BRAIN ANEURYSM. DUE TO THE RESULTS OF A PREVIOUS SURGERY, THE PATIENT'S VESSELS WERE DIFFICULT TO ACCESS. THE PHYSICIAN ATTEMPTED ACCESS WITH A FIRST GUIDEWIRE/CATHETER COMBINATION BUT COULD NOT GAIN ACCESS. THE PHYSICIAN THEN CHANGED THE GUIDEWIRE AND MICROCATHETER, BUT AGAIN COULD NOT GAIN ACCESS TO THE TARGET AREA. THE GUIDEWIRE WAS THEN REPLACED WITH THE MIRAGE GUIDEWIRE, BUT AGAIN ACCESS WAS NOT ACHIEVED. ANGIOGRAPHY WAS THEN PERFORMED, WHICH INDICATED THAT A VESSEL PERFORATION HAD OCCURRED. THE PHYSICIAN DID NOT KNOW WHICH GUIDEWIRE CONTRIBUTED TO THE EVENT. THE PERFORATION LED TO A SUBDURAL HEMATOMA. A CRANIOTOMY WAS PERFORMED TO TREAT/EVALUATE THE PATIENT. THE PATIENT RECOVERED BACK TO THE PRE-OPERATIVE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE HYDROPHILIC GUIDEWIRE GUIDEWIRE DQX MICRO THERAPEUTICS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention TRANSEND-EX GUIDEWIRE.