BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 MICROCATHETER

    MDR report key: 885104 · Received September 14, 2006

    Report

    Report Number
    6000078-2004-00254
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    January 15, 2004
    Report Date
    January 20, 2004
    Manufacturer
    NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO BOSTON SCIENTIFIC FOR EVAL (COIL, GUIDEWIRE AND FOREIGN MATERIAL WERE NOT RETURNED). A DEVICE HISTORY RECORD (DHR) REVIEW, A SIMILAR COMPLAINTS REVIEW, A DIMENSIONAL CHECK, A FUNCTIONAL CHECK, AN INITIAL CONDITION EXAM AND A VISUAL/MICROSCOPIC EXAM WERE PERFORMED AS PART OF THE DEVICE EVAL. THE DHR REVIEW SHOWED NO ISSUES OR DISCREPANCIES, INDICATING THAT ALL PROCESSES AND TESTS WERE CARRIED OUT ACCORDING TO SPECIFICATIONS AT THE TIME OF THE BUILD. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO OTHER COMPLAINTS ASSOCIATED WITH THIS BATCH. THE DIMENSIONAL CHECK DETERMINED THE DEVICE IN QUESTION TO BE WITHIN SPEC FOR RELEVANT DIMENSIONS. THE FUNCTIONAL CHECK DETERMINED THE DEVICE IN QUESTION TO BE WITHOUT PROBLEM (A SAMPLE COIL WAS INSERTED INTO THE DEVICE IN QUESTION AND THE PRODUCT FUNCTIONED WITHOUT PROBLEM). THE DEVICE IN QUESTION WAS RETURNED WITHOUT THE COIL, GUIDEWIRE AND FOREIGN MATERIAL (NO ANALYSIS POSSIBLE). NO ANOMALIES WERE OBSERVED IN THE INITIAL CONDITION AND VISUAL/MICROSCOPIC EXAMS. BASED ON THE ABOVE FACTS AND FINDINGS, THE USER'S COMPLAINT WAS NOT CONFIRMED. THE DEVICE IN QUESTION WAS FOUND TO BE WITHIN IT'S DIMENSIONAL AND FUNCTIONAL SPECIFICATIONS. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF FURTHER SIGNIFICANT INFO IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. ADDITIONAL PMA/510(K) NUMBERS: K042568, K994155.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: THE HOSP REPORTED AN EMBOLIZATION PROCEDURE IN THE BASILAR ARTERY TIP. THE HOSP REPORTED THE EMBOLIZATION WAS PERFORMED. THE DEVICE IN QUESTION AND GUIDEWIRE WERE ADVANCED TO THE ANEURYSM, AND THE TIP OF THE DEVICE IN QUESTION WAS INSERTED INTO THE ANEURYSM. THE GUIDEWIRE WAS REMOVED AND THE COIL WAS INSERTED. THOUGH THE DEVICE IN QUESTION'S POSITION WAS CHANGED AND THE COIL COULDN'T BE DEPLOYED BECAUSE IT WAS TOO SMALL, THE SYSTEM WAS PULLED OUT. WHEN THE COIL WAS PULLED OUT AND THE DEVICE IN QUESTION WAS FLUSHED OUTSIDE THE BODY, FOREIGN MATERIAL WAS FLUSHED OUT OF THE CATHETER. THE USER SUSPECTS THIS MATERIAL WAS THE INNER LUMEN OF THE DEVICE IN QUESTION. THEREFORE, THE USER WOULD LIKE TO KNOW THE ANALYSIS OF THE INNER LUMEN AND THIS MATERIAL. THE HOSP REPORTED THAT THE PT STATUS AFTER THE PROCEDURE WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 MICROCATHETER INFUSION CATHETER DQO NEUROVASCULAR, A DIV OF BOSTON SCIENTIFIC CORP 168189 5795262

    Patients

    Seq Age Sex Outcome Treatment
    1 * TRANSEND GUIDEWIRE| GDC COIL