BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX .014" / 205 PLATINUM

    MDR report key: 842504 · Received April 20, 2007

    Report

    Report Number
    6000078-2007-00115
    Event Type
    Injury
    Date Received
    April 20, 2007
    Date of Event
    March 21, 2007
    Report Date
    March 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    DQX
    PMA / PMN Number
    k923480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) ON 03/22/2007, THAT A CUSTOMER ENCOUNTERED PROBLEMS DURING USE OF A GUIDEWIRE. THE FOLLOWING INFO WAS REPORTED TO THE MANUFACTURER: PATIENT PRE-PROCEDURE CONDITION: PT WAS BEING TREATED AFTER 20 DAYS OF HUNT HESS III SUBARACHNOID HEMORRHAGE. HE ENTERED WITHOUT NEUROLOGICAL FOCUS. PROCEDURE SUMMARY: DURING ENDOVASCULAR TREATMENT OF AN ANTERIOR COMMUNICATING ANEURYSM, AND BSC MICROCATHETER WAS ADVANCED OVER AN BSC GUIDEWIRE [DEVICE IN QUESTION]. WHEN THE MICROCATHETER WAS AT THE STAGE OF THE SUPRACLINOID CAROTID, WITH THE GUIDE TIP [DEVICE IN QUESTION] OUTSIDE THE CATHETER, THE GUIDEWIRE [DEVICE IN QUESTION] BROKE. AS THE GUIDEWIRE [DEVICE IN QUESTION] COULD NOT BE POSITIONED AT A1, IT WAS DECIDED TO REMOVED THE GUIDEWIRE [DEVICE IN QUESTION] IN ORDER TO CHANGE THE CURVE. AT THE MOMENT, IT WAS OBSERVED THAT EVEN WHEN THE GUIDEWIRE [DEVICE IN QUESTION] WAS BEING REMOVED, THE TIP OF THE GUIDE [DEVICE IN QUESTION] DID NOT MOVE AT THE RADIOSCOPE. AS THERE WAS RISK THAT THE LOOSE TIP OF THE GUIDEWIRE [DEVICE IN QUESTION] MIGHT REMAIN IN THE ARTERY OR MIGRATE DISTALLY, THE MICROCATHETER WAS TAKEN BACKWARDS UNDER NEGATIVE PRESSURE, AND THE GUIDE TIP [DEVICE IN QUESTION] WAS RECOVERED. ANGIOGRAPHIC CONTROL SHOWED WORSENING OF THE PROXIMAL VESSEL SPASM IN THE SUPRACLINOID CAROTID, WHICH GENERATED DISTAL HYPOFLOW. FOR THAT REASON, IT WAS DECIDED TO INTERRUPT THE PROCEDURE. WHILE RECOVERING FROM THE ANESTHESIA, THE PT HAD SEVERE LEFT HEMIPARESIA, WHICH CEASED AFTER ONE HOUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014" / 205 PLATINUM HAP: GUIDEWIRE DQX BOSTON SCIENTIFIC CORP. 46-808 9081305

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other EXCEL 14 MICROCATHETER