BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX. 014"/205 PLATINUM

    MDR report key: 599325 · Received April 29, 2005

    Report

    Report Number
    6000078-2005-00052
    Event Type
    Malfunction
    Date Received
    April 29, 2005
    Date of Event
    March 24, 2005
    Report Date
    April 28, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED THAT DURING AND EMBOLIZATION OF A POSTERIOR CEREBRAL ARTERY ANEURYSM A 7F BRITE TIP 90-CM ST CORDIS CATHETER WAS ADVANCED TO THE VERTEBRAL ARTERY. AFTER THAT, THE TRANSEND EX .014"/205 PLATINUM GUIDEWIRE WAS APPROACHED TO THE LESION USING A PROWLER-14 2-MARKER AND A FRACTURE WAS FELT. THE FRACTURE WAS FOUND AT 5-CM FROM THE TIP OF THE TRANSEND EX .014"/205 PLATINUM GUIDEWIRE. THE BROKEN TIP WAS RETRIEVED FROM THE MICROCATHETER WITH A GOOSENECK SNARE. NO COMPLICATIONS WERE REPORTED TO HAVE OCCURRED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * TYPE OF DEVICE: CATHETER.| TYPE OF DEVICE: CATHETER| BRAND NAME: 7F BRITE TIP 90-CM ST CORDIS CATHETER| BRAND NAME: PROWLER-14-2-MARKER