BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIOR SL-10 MICROCATHETER

    MDR report key: 1558131 · Received December 8, 2009

    Report

    Report Number
    2939204-2009-00885
    Event Type
    Injury
    Date Received
    December 8, 2009
    Date of Event
    February 7, 2009
    Report Date
    November 18, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K013789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K): K042568. ANTICIPATED PROCEDURAL COMPLICATION. THE DEVICE 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. A REVIEW OF THE LABELING FOUND THAT THROMBOSIS IS NOTED AS AN ANTICIPATED PROCEDURAL COMPLICATION ASSOCIATED WITH SUCH PROCEDURES. IN ADDITION, THE PHYSICIAN STATED THAT THE EVENT WAS RELATED TO THE MANIPULATION OF THE MICROCATHETER SO IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THIS REPORT IS RELATED TO MANUFACTURER REPORT # 2939204-2009-00435, 2939204-2009-00436 AND 2939204-2009-00437.

    Description of Event or Problem · 1

    FINAL ANGIOGRAPHY FOLLOWING THE COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ANEURYSM (ACOM) DEMONSTRATED THE COMPLETE OBLITERATION OF THE ANEURYSM AND A FILLING DEFECT ALONG A BRANCH DIVISION OF THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) DUE TO A SMALL THROMBUS. THE MICROCATHETER WAS NAVIGATED INTO THE MCA BRANCH WITH THE CLOT AND 7MG OF REOPRO WAS INJECTED RESULTING IN THE RECANALIZATION OF THE VESSEL. AT THE END OF THE PROCEDURE THERE WAS NO CLOT NOTED AND CIRCULATION THROUGH THE RIGHT MCA AND ITS BRANCHES WAS NORMAL. THE PHYSICIAN STATED THAT THE THROMBUS WAS RELATED TO THE "MANIPULATION OF THE MICROCATHETER." THERE WAS NO REPORTED CLINICAL CONSEQUENCE AND THE PATIENT WAS DISCHARGED TEN DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 MICROCATHETER DQY NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention GDC COIL (BOSTON SCIENTIFIC)| TWO MATRIX2 COILS