BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1161568 · Received September 15, 2008

    Report

    Report Number
    3005099803-2008-04528
    Event Type
    Malfunction
    Date Received
    September 15, 2008
    Report Date
    August 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, INFLATION DIFFICULTIES WERE ENCOUNTERED. THE LESION WAS LOCATED IN THE ESOPHAGUS. THE CRE 15MM X 18MM DILATATION BALLOON WAS ADVANCED TO THE LESION, HOWEVER, THE BALLOON WAS UNABLE TO BE INFLATED. THE BALLOON CATHETER WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC M00558430 11702449

    Patients

    Seq Age Sex Outcome Treatment
    1