BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 MICROCATHETER

    MDR report key: 1478991 · Received July 10, 2009

    Report

    Report Number
    2939204-2009-00549
    Event Type
    Malfunction
    Date Received
    July 10, 2009
    Date of Event
    June 11, 2009
    Report Date
    June 11, 2009
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIV.
    Product Code
    DQY
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L PMA/510(K): K042568/K994155.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING SOME RESISTANCE BETWEEN THE MICROCATHETER (SUBJECT DEVICE) AND GUIDEWIRE, THE PHYSICIAN NOTICED AN UNK MATERIAL CAME OUT OF THE DISTAL END OF THE MICROCATHETER. THE PT IS REPORTED TO BE FINE. NO FURTHER DETAILS HAVE BEEN DISCLOSED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 MICROCATHETER DQY BOSTON SCIENTIFIC, NEUROVASCULAR DIV. M0031681890 12384650

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSEND GUIDEWIRE (BOSTON SCIENTIFIC)