BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER

    MDR report key: 1181727 · Received September 30, 2008

    Report

    Report Number
    3005099803-2008-04931
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 3, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNQ
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLONOSCOPY PROCEDURE, INFLATION DIFFICULTIES AND BALLOON DAMAGE WAS NOTED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE COLON. THE CRE 12MM X 15MM BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION. UPON ATTEMPTING OT INFLATE THE BALLOON TO 12MM, THE BALLOON WAS UNABLE TO BE INFLATED. A SECOND ATTEMPT WAS MADE TO INFLATE THE BALLOON, HOWEVER, THE BALLOON WAS AGAIN UNABLE TO BE INFLATED AND THE PHYSICIAN NOTED THAT SEVERAL HOLES WERE VISIBLE IN THE BALLOON. 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 "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. ESOPHAGEAL/PYLORIC WIREGUIDED BALLOON DILATATION CATHETER KNQ - BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC M00558480 11810836

    Patients

    Seq Age Sex Outcome Treatment
    1