BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPY FLUORESCENCE IMAGING SYSTEM

    MDR report key: 6301682 · Received February 3, 2017

    Report

    Report Number
    3012345110-2017-00001
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 5, 2017
    Report Date
    February 3, 2017
    Manufacturer
    NOVADAQ TECHNOLOGIES INC.
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A BREAST RECONSTRUCTIVE SURGICAL PROCEDURE THE PATIENT EXPERIENCED AN ANAPHYLACTIC REACTION UPON ADMINISTRATION OF ICG, WHICH WAS MANUFACTURED BY DIAGNOSTIC GREEN (B)(4). SINCE THE SPY SYSTEM (MANUFACTURED BY NOVADAQ TECHNOLOGIES INC.) WAS PLANNED TO BE USED DURING THE PROCEDURE TO VIEW THE FLAP, NOVADAQ IS SUBMITTING THIS MEDWATCH REPORT FORM AS THE MEDICAL DEVICE MANUFACTURER OF THE SPY SYSTEM BECAUSE THE SPY SYSTEM IS USED IN COMBINATION WITH THE ICG (I.E. A COMBINATION PRODUCT). ADVERSE EVENT WAS RELATED TO THE ICG

    Description of Event or Problem · 1

    A FEMALE PATIENT HAD BEEN UNDER ANESTHESIA FOR ABOUT 2.5 HOURS DURING A DIEP FLAP BREAST RECONSTRUCTIVE SURGICAL PROCEDURE WHEN ICG (INDOCYANINE GREEN) IMAGING AGENT WAS ADMINISTERED. ICG WAS ADMINISTERED DIRECTLY PRIOR TO USING THE SPY FLUORESCENCE IMAGING SYSTEM (SPY SYSTEM) TO VIEW THE FLAP PRIOR TO LIFTING. DURING THE PROCEDURE THE PATIENT WAS IN A SUPINE POSITION AND WAS INTUBATED AND UNDER ANESTHESIA. THE PATIENT HAD NO HISTORY OF ANY ALLERGIES OR PROBLEMS WITH CONTRAST DYES, AND NO SIGNIFICANT MEDICAL HISTORY. ABOUT 2 MINUTES AFTER ICG WITH SALINE BOLUS WAS ADMINISTERED TO THE PATIENT, THE PATIENT'S BLOOD PRESSURE DECREASED TO ABOUT 60/40 AND THEY HAD SOME DIFFICULTY BRINGING IT UP TO BASELINE, WHICH WAS ABOUT 140/90 IN THE MORNING PRIOR TO SURGERY. THE PHYSICIAN ADMINISTERED ADDITIONAL FLUIDS AND POSSIBLY A VASOPRESSOR TO GET THE BLOOD PRESSURE BACK UP TO NORMAL. ONCE THE BLOOD PRESSURE WAS STABILIZED THEY DECIDED TO CANCEL THE CASE AS IT WAS TOO RISKY TO PROCEED AFTER THE EVENT, WHICH THEY ARE CALLING "ANAPHYLAXIS DUE TO THE ICG".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85554 SPY FLUORESCENCE IMAGING SYSTEM SPY SYSTEM IZI NOVADAQ TECHNOLOGIES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other