BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RX DILATATION BALLOON

    MDR report key: 1070407 · Received July 3, 2008

    Report

    Report Number
    3005099803-2008-01059
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 4, 2008
    Report Date
    June 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KOG
    PMA / PMN Number
    K833417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS REPORTED FOR THE SAME LOT. THE 2008 15-MONTH BILIARY DILATOR PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A RX DILATATION BALLOON WAS USED DURING A ENDOSCOPIC DILATATION AND STENT PLACEMENT PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, "THE PHYSICIAN ATTEMPTED THE PROCEDURE WITHOUT WATER, FIRST USING ONLY AIR, THEN PUT IN CONTRAST AND INFLATED IT. THE BALLOON BROKE." THE PROCEDURE WAS COMPLETED WITH ANOTHER RX DILATATION BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX DILATATION BALLOON KOG BOSTON SCIENTIFIC CORK LTD. M00545900 8453817

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR