BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND GUIDEWIRE

    MDR report key: 1020726 · Received March 26, 2008

    Report

    Report Number
    2939204-2008-00103
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 27, 2008
    Manufacturer
    NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K964611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM: DEVICE ENTANGLED.

    Description of Event or Problem · 1

    THE STENT DEPLOYMENT WAS UNEVENTFUL ACROSS THE NECK OF THE ANEURYSM. THE PHYSICIAN WAS ATTEMPTING TO ACCESS THE ANEURYSM WITH A MICROCATHETER AND GUIDEWIRE [SUBJECT DEVICE] WHEN HE BELIEVED THAT THE STENT HAD PROLAPSED INTO THE ANEURYSM. AS HE ATTEMPTED TO POSITION THE DEVICES BETWEEN THE STENT AND THE PARENT VESSEL WALL TO ACCESS THE ANEURYSM, THE CATHETER AND GUIDEWIRE BECAME ENTRAPPED IN THE STENT. AS THE CATHETER AND GUIDEWIRE WERE PULLED BACK, THE STENT MIGRATED WITH THE DEVICES. THE PHYSICIAN CHOSE TO PULL THE STENT PROXIMAL TO THE ANEURYSM, SO THAT IT NO LONGER COVERED THE ANEURYSM NECK. THE CATHETER AND GUIDEWIRE WERE "DISENTANGLED" FROM THE STENT BY "TORQUING THE CATHETER". THE STENT WAS LEFT IN PLACE, PROXIMAL TO THE ANEURYSM AND THE MICROCATHETER AND GUIDEWIRE WERE REMOVED FROM THE PT. USING A NEW MICROCATHETER AND GUIDEWIRE, THE PHYSICIAN SUCCESSFULLY EMBOLIZED THE ANEURYSM WITH TEN COILS AND THE "ANGIOGRAPHIC RESULT WAS FINE". A POST PROCEDURE CT SCAN WAS PERFORMED AND "METALLIC PARTICLES" WERE OBSERVED RESULTING IN MICRO EMBOLI. THE PT DID NOT DEMONSTRATE ANY CLINICAL SYMPTOMS FROM THE EMBOLI AND IS REPORTED AS "DOING FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSCEND GUIDEWIRE (DQX) GUIDEWIRE, CATHETER DQX NEUROVASCULAR DIV, BOSTON SCIENTIFIC CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other TWO TRANSEND GUIDEWIRES| TEN BOSTON SCIENTIFIC GDS COILS| TWO EXCELSIOR SL-10 MICROCATHETERS