BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE FIXED WIRE

    MDR report key: 2223717 · Received August 15, 2011

    Report

    Report Number
    2223717
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AR, US

    Narratives

    Description of Event or Problem · 1

    THE BALLOON DILATOR WAS REMOVED FROM THE PACKAGE IN THE USUAL FASHION, NO APPARENT DEFECTS WERE VISIBLE. THE PACKAGING WAS INTACT AND THE TIP COVERING THE BALLOON WAS INTACT. WHILE ATTEMPTING TO INFLATE THE BALLOON TO DILATE, THERE WAS NO RESISTANCE AND WATER WAS GONE FROM THE SYRINGE. THE BALLOON DILATOR WAS THEN REMOVED FROM THE PT. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON AGAIN TO VISUALIZE THE WATER FLOWING FROM THE BOTTOM OF THE BALLOON. THERE WAS NO PT INJURY. THE DEVICE AND PACKAGING WERE RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE FIXED WIRE ESOPHAGEAL BALLOON DILATION CATHETER KNQ BOSTON SCIENTIFIC * 14363664

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR NO OTHER THERAPIES