BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIOR MICROCATHETER

    MDR report key: 1693250 · Received May 18, 2010

    Report

    Report Number
    2939204-2010-00468
    Event Type
    Injury
    Date Received
    May 18, 2010
    Date of Event
    July 4, 2006
    Report Date
    July 4, 2006
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DQY
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA# OR 510K#: K013789. FOR ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. FROM THE INFORMATION PROVIDED THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ANEURYSM RUPTURE AND HEMORRHAGE ARE KNOWN AND ANTICIPATED COMPLICATIONS TO THESE TYPES OF PROCEDURES AND ARE NOTED IN THE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION OF THE RIGHT CAROTID BIFURCATION ANEURYSM, THE ANEURYSM RUPTURED WITH AN ASSOCIATED HEMORRHAGE. IMMEDIATELY POST PROCEDURE, THE PATIENT¿S CONDITION HAD WORSENED RELATED TO ¿IATROGENIC CAUSES¿, NO DETAILS WERE PROVIDED. SEVENTEEN DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED WITH IMPROVEMENT AND GOOD RECOVERY. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING THE COIL EMBOLIZATION OF THE RIGHT CAROTID BIFURCATION ANEURYSM, THE ANEURYSM RUPTURED WITH AN ASSOCIATED HEMORRHAGE. IMMEDIATELY POST PROCEDURE, THE PATIENT¿S CONDITION HAD WORSENED RELATED TO ¿IATROGENIC CAUSES¿, NO DETAILS WERE PROVIDED. SEVENTEEN DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED WITH IMPROVEMENT AND GOOD RECOVERY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR MICROCATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - CORK UNK235

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other ONE MATRIX COIL (BOSTON SCIENTIFIC)