MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES INC. SPY FLUORESCENCE IMAGING SYSTEM; SPY SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/05/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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".

• Brand Name: SPY FLUORESCENCE IMAGING SYSTEM
• Type of Device: SPY SYSTEM
• Manufacturer (Section D): NOVADAQ TECHNOLOGIES INC.; 8329 eastlake drive, unit 101; burnaby, british columbia V5A4W 2; CA V5A4W2
• Manufacturer (Section G): DIAGNOSTIC GREEN GMBH; fuerstenrieder str. 105; munich, 80686 ; GM 80686
• Manufacturer Contact: ann maloney ; 3773 attucks drive; powell, OH 43065 ; 1844424842
• MDR Report Key: 6301682
• MDR Text Key: 166036300
• Report Number: 3012345110-2017-00001
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other