BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX .014"/205 PLATINUM

    MDR report key: 541072 · Received August 26, 2004

    Report

    Report Number
    6000078-2004-00124
    Event Type
    Injury
    Date Received
    August 26, 2004
    Date of Event
    July 21, 2004
    Report Date
    August 25, 2004
    Manufacturer
    BOSTON SCIENTIFIC CORP./NEUROVASCULAR DIVISION
    Product Code
    DQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED OF THE FOLLOWING EVENT THAT OCCURRED ON A PT, WHO SUFFERED SUBARACHNOID BLEEDING BEFORE THE PROCEDURE AND DIAGNOSED WITH A LEFT-SIDED PERICALLOSAL ANEURYSM (AN ADD'L LEFT-SIDED MIDDLE CEREBRAL ARTERY ANEURYSM WAS ALSO PRESENT). THE PT PRESENTED "NUCLEAR" RIGIDITY PRIOR TO THE INTERVENTION WITHOUT ANY ADD'L SYMPTOM. THE AIM OF THE PROCEDURE WAS TO OCCLUDE THE PERICALLOSAL ANEURYSM WITH GDC COILS. WHILE ATTEMPTING TO ADVANCE THE TRANSEND EX .014"/205 PLATINUM GUIDEWIRE TO THE LEFT ANTERIOR CEREBRAL ARTERY, THE DISTAL PART BROKE AND THE BLOOD FLOW TOOK IT AWAY TO THE MIDDLE CEREBRAL ARTERY. FINALLY, THE DISTAL SEGMENT GOT STUCK IN THE MCA ANEURYSM. AFTERWARDS, THE BLOOD FLOW IN THE MCA GOT INTERRUPTED, SUGGESTING THAT THROMBOSIS OCCURRED IN THE ARTERY. HEPARIN WAS ADMINISTERED INSTANTLY, THE PERICALLOSAL ARTERY WAS OCCLUDED WITH 5 GDC COILS. AFTER THE INTERVENTION, THE PT PRESENTED A RIGHT-SIDED WEAKNESS AND DYSPHASIA. ACCORDING TO THE INTERVENTIONIST, THE FRACTURE OF THE GUIDEWIRE CANNOT BE ATTRIBUTED TO THE TECHNICAL CIRCUMSTANCES OF THE PROCEDURE, BUT IT COULD BE RELATED TO THE QUALITY ISSUES WITHIN THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014"/205 PLATINUM GUIDEWIRE DQX BOSTON SCIENTIFIC CORP./NEUROVASCULAR DIVISION * 6484774

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR 3) BRAND NAME: SENTRY BALLOON CATHETER,| 2) BRAND NAME: MAVERICK XL BALLOON,| 4) BRAND NAME: RETRIEVER-10, MODEL#: 600001.| 1) BRAND NAME: GUIDER 6F MP XF,