BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C.R.E. BALLOON DILATATION CATHETER

    MDR report key: 1171174 · Received September 22, 2008

    Report

    Report Number
    3005099803-2008-04758
    Event Type
    Injury
    Date Received
    September 22, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATATION PROCEDURE, DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE ESOPHAGUS. THE CRE 18MM X 20MM DILATATION BALLOON WAS ADVANCED TO THE LESION AND INFLATED AN UNKNOWN NUMBER OF TIMES TO UNKNOWN ATMS. ON THE FINAL INFLATION, THE BALLOON FAILED TO DEFLATE AND WAS UNABLE TO BE REMOVED THROUGH AN UNSPECIFIED ENDOSCOPE. IT WAS NOTED THAT THERE WAS NO USE OF SILICON AND NEGATIVE PRESSURE WAS NOT BELIEVED TO HAVE BEEN USED IN THE ATTEMPT TO DEFLATE THE BALLOON. THE BALLOON AN ENDOSCOPIES WERE REMOVED AS A UNIT. THE ESOPHAGUS HAD BEEN ADEQUATELY DILATED, THEREFORE, THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INTERVENTION. THE PT'S STATUS IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. BALLOON DILATATION CATHETER KNQ - BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC M00558380 0011767756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention