BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATION CATHETER

    MDR report key: 1230964 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05544
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Report Date
    September 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED BALLOON DILATION PROCEDURE, A BALLOON BREAK OCCURRED. AN UNSPECIFIED TYPE OF CRE BALLOON CATHETER HAD BEEN ADVANCED THROUGH A GASTROSCOPE TO TREAT AN UNSPECIFIED LESION. AT AN UNSPECIFIED TIME DURING THE PROCEDURE, THE BALLOON "BROKE". IT WAS REPORTED THAT THE BALLOON WAS USED IN A WORKING CHANNEL THAT WAS SMALLER THAN DEVICE REQUIREMENTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATION CATHETER KNQ BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1