BEUDAMED
    FDA Adverse Event Other Summary report: N

    STELLARTECH COAGULATION CATHETER

    MDR report key: 686380 · Received March 7, 2006

    Report

    Report Number
    2952366-2006-00005
    Event Type
    Other
    Date Received
    March 7, 2006
    Date of Event
    September 26, 2005
    Report Date
    March 4, 2006
    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 PATIENT WAS TREATED FOR BARRETT'S ESOPHAGUS LATE 2005. TWO WEEKS AFTER THE TREATMENT THE PATIENT DEVELOPED DYSPHAGIA AND WAS ADMITTED IN THE HOSPITAL. AN ENDOSCOPIC EVALUATION WAS PERFORMED THAT REVEALED A SOFT STRICTURE. THE PATIENT WAS DILATED WITHOUT ANY DIFFICULTY. THIS EVENT IS TRANSIENT IN NATURE, TREATABLE AND NOT LIFE THREATIENING TO THE PATIENT. NO DEVICE MALFUNCTION WAS REPORTED FOR THIS DEVICE.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT TO THE REPORT 2952366-2006-00005: ADDITIONAL INFORMATION OBTAINED ON 3-21-2006 REGARDING A PT THAT HAD A STRICTURE FORMATION. THE PT HAD A HISTORY OF HGD AND WAS LASERED WITH ND: YAG LASER PREVIOUSLY, WHICH MAY PREDISPOSE TO STRICTURE FORMATION. THE PT WAS SUCCESSFULLY DILATED, AND IS CURRENTLY WITHOUT STRICTURE.

    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