BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 819691 · Received February 5, 2007

    Report

    Report Number
    6000078-2007-00029
    Event Type
    Malfunction
    Date Received
    February 5, 2007
    Date of Event
    November 1, 2005
    Report Date
    January 8, 2007
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATON
    Product Code
    NIM
    PMA / PMN Number
    H020002/S4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE'S MODEL AND LOT NUMBERS WERE NOT DISCLOSED, THEREFORE, THE DATE THE DEVICE WAS MANUFACTURED WAS UNABLE TO BE DETERMINED. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS. ADD'L PMA/510(K) #H020002/S5.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE PATIENT HAD MULTIPLE LOOPS WITHIN THE INTERNAL CAROTID ARTERY (ICA) CAUSING DIFFICULTY IN ADVANCING THE STENT. ONCE THE STENT WAS ADVANCED INTO PLACE, IT WAS NOTED THAT THERE WOULD NOT BE ENOUGH OVERLAP ON EITHER SIDE OF THE ANEURYSM EVEN WITH THE LARGEST STENT AVAILABLE. AT THAT TIME, IT WAS ALSO NOTED THAT THERE WAS A CATHETER BREAK WITHIN THE INFUSION CATHETER. THE ENTIRE SYSTEM WAS REMOVED. THE ARTERY WAS THEN OCCLUDED AND THE ANEURYSM WAS COILED. THE PATIENT NEVER RECEIVED THE STENT. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK NIM NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR