BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX .014" / 205 PLATINUM

    MDR report key: 777015 · Received November 1, 2006

    Report

    Report Number
    6000078-2006-00536
    Event Type
    Injury
    Date Received
    November 1, 2006
    Date of Event
    September 12, 2006
    Report Date
    October 11, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION
    Product Code
    DQX
    PMA / PMN Number
    k923480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS NOT RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS AND THE USER FACILITY DID NOT PROVIDE A REASON AS TO WHY THE DEVICE COULD NOT BE RETURNED. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IS RETURNED, AND FURTHER SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE PATIENT HAD PRESENTED WITH A HEMORRHAGE AND A KNOWN CEREBELLAR ARTERIOVENOUS MALFORMATION IN 2006. AN ANGIOGRAM DEMONSTRATED DISTAL LEFT POSTERIOR INFERIOR CEREBELLAR ARTERY ANEURYSM (PICA), AS THE SOURCE OF THE BLEED. THE PATIENT UNDERWENT AN ATTEMPTED EMBOLIZATION OF THE ANEURYSM. DURING THE MANIPULATION OF THE GUIDEWIRE AND AN ATTEMPT TO CATHETERIZE THE PICA ANEURYSM, THE DISTAL 10 CM OF THE GUIDEWIRE FRACTURED AND SEPARATED FROM THE MAIN WIRE. THE PROXIMAL END OF THE GUIDEWIRE EXTENDED DOWN TO THE C1 LEVEL OF THE LEFT VERTEBRAL ARTERY. THE PATIENT WENT TO THE OPERATING ROOM (OR) FOR RETRIEVAL OF THE GUIDEWIRE AND LIGATION OF THE ANEURYSM. NO ADDITIONAL DETAILS REGARDING THIS COMPLAINT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND EX .014" / 205 PLATINUM (74 HAP) GUIDE WIRE DQX BOSTON SCIENTIFIC CORP., NEUROVASCULAR DIVISION 46-808 8842974

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention