BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE ESOPHAGEAL/PYLORIC/COLONIC WIREGUIDED BALLOON DILATATION CATHETER

    MDR report key: 1242898 · Received November 19, 2008

    Report

    Report Number
    3005099803-2008-06560
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Report Date
    October 20, 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 A GASTRO-INTESTINAL (G.I.) DILATATION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN AN UNSPECIFIED PORTION OF THE LARGE BOWEL. THE CRE WG 15MM X 18MM DILATATION BALLOON WAS ADVANCED TO THE LESION, HOWEVER, THE BALLOON BURST PRIOR TO REACHING 7 ATMS ON AN UNSPECIFIED INFLATION. THE DEVICE WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. THE PT'S STATUS IS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE ESOPHAGEAL/PYLORIC/COLONIC WIREGUIDED BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC M00558490 9774041

    Patients

    Seq Age Sex Outcome Treatment
    1