BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX .014"/205 FLOPPY

    MDR report key: 837268 · Received February 16, 2007

    Report

    Report Number
    6000078-2007-00052
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Date of Event
    January 15, 2007
    Report Date
    January 22, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K923480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC AS IT WAS DISPOSED OF BY THE HOSPITAL. THEREFORE, THE CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS PERFORMING AN ENDOVASCULAR THERAPY FOR A CEREBRAL ANEURYSM EMBOLIZATION. THE PHYSICIAN REPORTEDLY OPENED AND FLUSHED THE GUIDEWIRE WITH STERILE SALINE SOLUTION. THE PHYSICIAN THEN ADVANCED THE GUIDEWIRE ACROSS THE STENT SYSTEM. IT WAS AT THE POINT, THE GUIDEWIRE BROKE. THE NURSE DISPOSED OF THE GUIDEWIRE IMMEDIATELY. THE PHYSICIAN OPENED ANOTHER GUIDEWIRE AND COMPLETED THE PROCEDURE. THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014"/205 FLOPPY (74 HAP) GUIDEWIRE DQX NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 46-807 9106451

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR NEUROFORM STENT SYSTEM (MODEL/LOT UNKNOWN)