BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLSTENT UNISTEP ENTERAL STENT

    MDR report key: 1081995 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01245
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC IRELAND, LTD
    Product Code
    MQR
    PMA / PMN Number
    K000281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS CURRENTLY UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A WALLSTENT UNISTEP ENTERAL STENT WAS PLACED DURING A GASTROSCOPY PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, THE WALLSTENT DEVICE WAS POSITIONED OVER THE TARGET OBSTRUCTION AT THE PYLORUS. WHEN THE PHYSICIAN STARTED TO DEPLOY THE STENT, RESISTANCE WAS FELT WHEN THE "VALVE BODY" WAS PULLED BACK. THE DELIVERY SYSTEM WAS REMOVED FROM THE GASTROSCOPE, WHERE THE PHYSICIAN NOTICED THAT THE STENT WIRES HAD PERFORATED THE EXTERIOR SHEATH, NEAR THE RADIOPAQUE MARKER BAND. IT WAS FURTHER REPORTED THAT THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE USING A SECOND WALLSTENT UNISTEP ENTERAL STENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WALLSTENT UNISTEP ENTERAL STENT MQR BOSTON SCIENTIFIC IRELAND, LTD M00565590 0011631801

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR