BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON CATHETER

    MDR report key: 1203623 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05295
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    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

    DEVICE ANALYSIS: THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD FOR CRE FIXED WIRE COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNK. ADD'L INFO RECEIVED REPORTS THAT A VACUUM WAS NOT APPLIED TO THE DEVICE PRIOR TO REMOVAL AND THAT THE BALLOON WAS NOT VISUALLY CHECKED TO BE FULLY DEFLATED BEFORE ATTEMPTING TO REMOVE THE DEVICE. THIS IS CONTRARY TO THE DIRECTIONS FOR USE. THEREFORE, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED COMPLAINT IS USER RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATION PROCEDURE, THE BALLOON FAILED TO FULLY DEFLATE. A CRE 18-20MM 8CM F/G BALLOON CATHETER HAD BEEN ADVANCED THROUGH AN UNSPECIFIED TYPE OF 2.8MM SCOPE TO AN UNSPECIFIED ESOPHAGEAL STRICTURE. A VACUUM WAS NOT MAINTAINED TO THE CATHETER DURING INSERTION OF THE DEVICE INTO THE SCOPE. THE BALLOON WAS INFLATED TO AN UNSPECIFIED PRESSURE FOR AN UNSPECIFIED AMOUNT OF TIME. DURING DEFLATION, IT WAS NOTICED THAT THE BALLOON WOULD NOT FULLY DEFLATE. A VACUUM WAS NOT APPLIED TO THE DEVICE BEFORE ATTEMPTING TO WITHDRAW THE BALLOON NOR WAS THE BALLOON VISUALLY CONFIRMED TO BE DEFLATED PRIOR TO ATTEMPTING TO WITHDRAW THE BALLOON. HOWEVER, THE DEVICE WAS ABLE TO BE WITHDRAWN INTO THE SCOPE BY UNSPECIFIED MEANS. THE PROCEDURE WAS CONSIDERED TO BE COMPLETE USING THIS DEVICE. THE BALLOON CATHETER WAS CUT IN ORDER TO REMOVE THE DEVICE FROM THE SCOPE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "STABLE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1