BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILHOUETTE XF 6F X 24CM

    MDR report key: 1200388 · Received October 15, 2008

    Report

    Report Number
    2027111-2008-00057
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    September 18, 2008
    Report Date
    October 15, 2008
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    FAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE ABSENCE OF THE INCIDENT DEVICE, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE AND FAILURE MODE. WE COULD NOT REVIEW THE DEVICE HISTORY RECORD OF THIS DEVICE DUE TO THE LOT NUMBER NOT BEING PROVIDED. AS A RESULT, WE ARE CONCLUDING OUR INVESTIGATION AND CLOSING THIS INCIDENT FILE. THIS DOCUMENT SERVES AS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    "PATIENT CAME INTO THE ER COMPLAINING OF FLANK PAIN AFTER RECEIVING A SILHOUETTE STENT 2 WEEKS PRIOR. AT THAT TIME DR WAS UNABLE TO THREAD A GUIDEWIRE THROUGH THE STENT AND CONCLUDED THAT THE STENT WAS OCCLUDED WITH SOME MATTER. REPLACED STENT WITH A COMPETITIVE PRODUCT. DR IS UNCOMFORTABLE USING SILHOUETTE AGAIN UNTIL A PROXIMAL AND DISTAL PORT ARE ADDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILHOUETTE XF 6F X 24CM SILHOUETTE STENT FAD APPLIED MEDICAL RESOURCES B3856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention