BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX PRECISION COLONIC STENT SYSTEM

    MDR report key: 1328260 · Received February 27, 2009

    Report

    Report Number
    3005099803-2009-00867
    Event Type
    Injury
    Date Received
    February 27, 2009
    Report Date
    January 30, 2009
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K030769
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. THE DEVICE IS NOT AVAILABLE. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: PROCEDURE AND EVENT DATES ARE UNKNOWN. IN 2009, A BOSTON SCIENTIFIC CORPORATION EMPLOYEE BECAME AWARE OF A CLINICAL STUDY ARTICLE, "ULTRAFLEX PRECISION COLONIC STENT PLACEMENT FOR PALLIATION OF MALIGNANT COLONIC OBSTRUCTION: A PROSPECTIVE MULTICENTER STUDY" PUBLISHED IN ENDOSCOPY 2007; VOLUME 66 NO. 5: 920-927. THE FOLLOWING INFORMATION WAS DERIVED FROM THIS ARTICLE: AN ULTRAFLEX PRECISION COLONIC SELF-EXPANDING METAL STENT DESIGNED FOR COLORECTAL USE WAS USED FOR A STENTING PROCEDURE OF A PATIENT WITH MALIGNANT COLONIC OBSTRUCTION. ACCORDING TO THE ARTICLE, DISTAL TUMOR PROGRESSION CAUSED OBSTRUCTIVE SYMPTOM RECURRENCE BY THE SIX-MONTH VISIT. THERE IS NO FURTHER INFORMATION FROM THE ARTICLE REGARDING THE STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX PRECISION COLONIC STENT SYSTEM MQR BOSTON SCIENTIFIC IRELAND, LTD. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other