BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP

    MDR report key: 1061621 · Received June 17, 2008

    Report

    Report Number
    3005099803-2008-00737
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD.
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN REQUESTED FOR EVAL; HOWEVER, THE ANALYSIS IS NOT COMPLETE. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT A WALLSTENT ENTERAL ENDOPROSTHESIS WAS PLACED IN '08. ACCORDING TO THE COMPLAINANT, AFTER THE STENT WAS DELIVERED TO THE TARGET LESION, THE NURSE WAS UNABLE TO COMPLETELY RELEASE THE STENT FROM THE DELIVERY SYSTEM. THE PHYSICIAN ELECTED TO RETRIEVE THE STENT, AND USED ANOTHER PRODUCT (DEVICE AND MFR ARE UNK) TO COMPLETE THE PROCEDURE. THE PT'S CONDITION WAS NOTED TO BE "STABLE" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP MQR BOSTON SCIENTIFIC IRELAND, LTD. M00565590 0011411706

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR