BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELSIOR SL10 MICROCATHETER

    MDR report key: 1101468 · Received August 6, 2008

    Report

    Report Number
    2939204-2008-00314
    Event Type
    Injury
    Date Received
    August 6, 2008
    Report Date
    July 11, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC HAS MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFO REGARDING THE ALLEGED EVENT WITHOUT RESULT. CURRENTLY, THERE ARE NO FURTHER DETAILS TO REPORT.

    Description of Event or Problem · 1

    AS A PEER REVIEW CONFERENCE, IT WAS REPORTED THAT THE PT HAD UNDERGONE STENT ASSISTED COIL EMBOLIZATION TO TREAT A BASILAR TIP ANEURYSM. EIGHT WEEKS POST PROCEDURE, THE PT WAS BEING TREATED FOR A REOCCURRENCE OF THE ANEURYSM. THE MICROCATHETER HAD BEEN PLACED WITHIN THE ANEURYSM WHEN DYE EXTRAVASATION WAS NOTED ON ANGIOGRAPHY, SUGGESTING THE VESSEL WAS PERFORATED. THE PHYSICIAN IMMEDIATELY REVERSED THE HEPARIN ANTICOAGULATION THERAPY, AND THE PT RECEIVED PLATELET THERAPY AND THE PT RECEIVED PLATELET THERAPY PRIOR TO UNDERGOING A VENTRICULOSTOMY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL10 MICROCATHETER (DQO) INFUSION CATHETER DQO NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT.| PREVIOUSLY PLACED BOSTON SCIENTIFIC NEUROFORM 3| PREVIOUSLY PLACED COILS