BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELLARTECH COAGULATION CATHETER

    MDR report key: 645187 · Received November 3, 2005

    Report

    Report Number
    2952366-2005-00001
    Event Type
    Injury
    Date Received
    November 3, 2005
    Date of Event
    September 26, 2005
    Report Date
    October 28, 2005
    Manufacturer
    STELLARTECH RESEARCH CORP
    Product Code
    KNQ
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TREATED FOR BARRETT'S ESOPHAGUS IN 2005. THREE WEEKS AFTER THE TREATMENT THE PT BEGAN DEVELOPING DIFFICULTY SWALLOWING. ONE MONTH FOLLOWING TREATMENT ENDOSCOPIC EVAL IDENTIFIED A CIRCUMFERENTIAL STRICTURE OF THE TREATMENT ZONE. THE PT UNDERWENT TWO DILATION SESSIONS THAT IMPROVED HIS DYSPHAGIA. IT IS THE TREATING PHYSICIAN'S OPINION THAT THE PT'S PRE-EXISTING HISTORY OF ULCERATION AND STRICTURE FORMATION OF THE ESOPHAGUS SECONDARY TO REFLUX DISEASE AND BARRETT'S ESOPHAGUS REQUIRING SERIAL DILATIONS OVER 23 YEARS PLAYED A ROLE IN THE POST ABLATION STRICTURE. THIS EVENT IS TRANSIENT IN NATURE, TREATABLE AND NOT LIFE THREATENING TO THE PT. NO DEVICE MALFUNCTION WAS REPORTED FOR THIS DEVICE.

    Description of Event or Problem · 1

    FOLLOW UP WITH THE PHYSICIAN ON 3/14/2006 CONFIRMED THAT THE PT IS DOING FINE. HE WAS DILATED SEVERAL TIMES LOCALLY AND BY 02/14/2006 HE WAS SWALLOWING WELL. THE STRICTURE WAS NOT TOTALLY GONE BUT IT IS ASYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELLARTECH COAGULATION CATHETER COAGULATION CATHETER KNQ STELLARTECH RESEARCH CORP NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| R