BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C.R.E. BALLOON DILATATION CATHETER

    MDR report key: 1082645 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01239
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGEAL DILATION PROCEDURE, THE BALLOON BURST. DURING PREPARATION FOR THE PROCEDURE, A CRE BALLOON CATHETER WAS KINKED AND WOULD NOT INFLATE. THIS BALLOON WAS THEN USED IN THE PROCEDURE AND BURST WHILE BEING INFLATED INSIDE THE PT. THE BALLOON WAS INFLATED TO 7 ATM AND 18MM IN DIAMETER AT THE TIME OF THE BURST. NO PIECES OF THE BALLOON DETACHED INSIDE THE PT. THE BALLOON CONTAINED STERILE WATER AND CONTRAST AT THE TIME OF THE EVENT, WHICH LEAKED INTO THE PATIENT'S STOMACH. THE STOMACH WAS FLUSHED AND SUCTION WAS USED TO REMOVE THE CONTRAST. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE BALLOON SUCCESSFULLY. THERE WERE NO PT COMPLICATIONS AND THE PT WAS NOTED TO BE FINE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C.R.E. BALLOON DILATATION CATHETER KNQ - BALLOON DILATATION CATHETER KNQ BOSTON SCIENTIFIC CORK LTD. M0058370 0011697178

    Patients

    Seq Age Sex Outcome Treatment
    1