BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIGUIDE

    MDR report key: 125259 · Received October 8, 1997

    Report

    Report Number
    8022170-1997-00001
    Event Type
    Death
    Date Received
    October 8, 1997
    Date of Event
    September 27, 1997
    Report Date
    October 7, 1997
    Manufacturer
    QLT PHOTOTHERAPEUTICS, INC.
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PHOTODYNAMIC THERAPY IS A TWO-STEP PROCESS INVOLVING BOTH INJECTION OF A PHOTOSENSITIZER AND ILLUMINATION WITH APPROPRIATE LIGHT DELVIERY DEVICES. QLT PHOTOTHERAPEUTICS INC. IS THE APPLICATION HOLDER FOR THE NDA OF THE DRUG PHOTOFRIN, AND OF THE PMA FOR THE DEVICE, OPTIGUIDE FIBER OPTIC DIFFUSER. THUS, THE CO HEREBY SUBMITS A JOINT SUSPECT ADVERSE EVENT REPORT FOR BOTH OF THESE PRODUCTS. THIS EVENT WILL ALSO BE REPORTED BY THE MFR OF THE LASER, COHERENT MEDICAL. THE PT WAS A 40-YR-OLD FEMALE TREATED FOR EXTENSIVE T1 ESOPHAGEAL ADENOCARCINOMA IN A BARRETT'S ESOPHAGUS BY A PHYSICIAN (INJECTION 9/22. LIGHT ADMINISTRATIONS 9/24 AND 25,1997). THE PT DIED IN HOSP ON 9/27 AND PRELIMINARY AUTOPSY RESULTS REVEALED DRAMATIC TRANSMURAL ISCHEMIC NECROSIS OF THE ENTIRE LENGTH OF THE TREATED ESOPHAGUS (14 CM), SEVERE ENOUGH TO RESULT IN PERFORATION IN PLACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIGUIDE FIBER OPTIC DIFFUSER GEX QLT PHOTOTHERAPEUTICS, INC. DCYL25 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death| H COHERENT PHOTODYNAMIC LASER 24-SEP-97 TO| 25-SEP-97