BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX PRECISION COLONIC STENT SYSTEM

    MDR report key: 1328251 · Received February 27, 2009

    Report

    Report Number
    3005099803-2009-00855
    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. ON JANUARY 30, 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 PATIENTS WITH MALIGNANT COLONIC OBSTRUCTION. ACCORDING TO THE ARTICLE, PATIENT EXPERIENCED RECURRENT OBSTRUCTIVE SYMPTOMS AND SEVERE DEVICE RELATED PAIN. PATIENT UNDERWENT SURGICAL PROCEDURE FOR STENT REMOVAL AND PERMANENT COLOSTOMY. 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| R