BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1063786 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00763
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PYLORIC DILATATION PROCEDURE, CATHETER DAMAGE AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE STENOSIS WAS LOCATED AT THE PYLORIC SPHINCTER. THE PROTECTIVE SLEEVE ON THE CRE 15MM X 18MM BALLOON DILATATION CATHETER WAS REMOVED AND THE DEVICE WAS ADVANCED THROUGH THE 2.8MM BIOPSY CHANNEL OF ANOTHER MANUFACTURER'S GASTROSCOPE. UPON EXITING THE CHANNEL, THE PHYSICIAN NOTED THAT THE "BLACK [EXIT MARKER] THAT ENCOMPASSES THE WELD BETWEEN THE CATHETER AND BALLOON" HAD BEEN DAMAGED. THE DAMAGE PREVENTED THE GASTROSCOPE FROM ADVANCING OVER THE CATHETER AND HINDERED VISUALIZATION OF BALLOON INFLATION. UPON ATTEMPTING TO REMOVE THE CATHETER, THE DEVICE WAS UNABLE TO BE RETRACTED INTO THE GASTROSCOPE. THE PHYSICIAN REMOVED THE GASTROSCOPE AND CATHETER AS A UNIT. FOLLOWING REMOVAL, THE PHYSICIAN "CUT THE CATHETER IN ORDER TO PULL IT OUT OF THE SCOPE". THE PROCEDURE WAS COMPLETED WITH AN 18MM X 20MM FIXED WIRE CRE BALLOON. THE PATIENT'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 M00558490 11628721

    Patients

    Seq Age Sex Outcome Treatment
    1 OLYMPUS GASTROSCOPE