BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1203346 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05269
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATION PROCEDURE, DEFLATION DIFFICULTY OCCURRED. THE CRE 18-20MM 8CM F/G DILATATION BALLOON, BEING USED IN THE ESOPHAGUS, WOULD NOT DEFLATE COMPLETELY. THE BALLOON WAS FULLY IN THE SCOPE BEFORE IT WAS REMOVED. THE BALLOON CATHETER HAD TO BE CUT TO REMOVE IT FROM THE SCOPE. THE PROCEDURE HAD BEEN COMPLETED WITH THIS DEVICE PRIOR TO THE EVENT. NO PATIENT COMPLICATIONS OCCURRED. PATIENT STATUS IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON CATHETER KNQ BOSTON SCIENTIFIC CORK LTD. M00558380

    Patients

    Seq Age Sex Outcome Treatment
    1