BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1063770 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00761
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    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 GASTRO-INTESTINAL (GI) DILATATION PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION WAS LOCATED IN THE ESOPHAGUS, HOWEVER, WHICH PORTION OF THE ESOPHAGUS IS UNK. THE CRE 12MM X 15MM BALLOON DILATATION CATHETER WAS ADVANCED TO THE LESION AND INFLATED TO 3ATMS FOR APPROX 1 MINUTE ON THE FIRST INFLATION. ON THE SECOND INFLATION, THE BALLOON WAS INFLATED TO 4.5ATMS FOR 1 MINUTE. ON THE THIRD INFLATION, THE BALLOON RUPTURED AT 8ATMS. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. 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 BALLOON DILATATION CATHETER KOG BOSTON SCIENTIFIC M00558420 11627358

    Patients

    Seq Age Sex Outcome Treatment
    1