Novasight Hybrid System Important Safety Information

Jurisdictions:

The Novasight Hybrid System is cleared for sale in the following jurisdictions (regulatory approvals referenced):

  • United States: FDA 510(k) clearance (K172258)
  • Canada: Health Canada medical device license (102500)
  • Japan: PMDA medical device license (catheter: 30200BZX00040000, console + PIM: 30200BZX00039000)

Caution:

The Novasight Hybrid System is restricted to sale by or on the order of a physician (prescription: for use by a qualified practitioner ONLY).

Indications for Use:

The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

Contraindications:

Use of the Novasight Hybrid Catheter is contraindicated:

  • Whenever tissue or organ damage is a reasonable probability.
  • Whenever major coagulation system abnormalities are present.
  • Whenever hemodynamic instability is present.
  • For patients that are not anti-coagulated during use of the catheter.
  • For patients diagnosed with coronary artery spasm.

Warnings:

  • In order to prevent the risk of ignition, make sure that flammable material is not present in the room during the use of the Novasight Hybrid System.
  • Do not use the Novasight Hybrid System if the sterile barrier system is breached at any point prior to use.
  • Do not use the Novasight Hybrid Catheter if any part of the catheter is damaged or no longer intact as this may cause damage to vascular tissue. Prior to use, inspect the Novasight Hybrid Catheter and do not use if any portion of the insertable section of the catheter is found to have unintended rough surfaces, sharp edges, or protrusions which may cause harm.
  • The Novasight Hybrid Catheter should only be used if the sterile barrier system indicators show that the contents have been sterilized, and the expiration date has not elapsed.
  • Do not resterilize or reuse the Novasight Hybrid Catheter. The Novasight Hybrid Catheter is a disposable device intended for single use only. Reuse, reprocessing, or resterilization may compromise the structural integrity of the catheter and/or lead to catheter failure which, in turn, may result in patient injury, illness, or death.
  • If resistance is felt during catheter advancement, immediately stop advancing the catheter. Do not forcibly insert the catheter into lumens narrower than the catheter sheath. Doing so may result in catheter damage and/or vessel injury.
  • Exercise caution when advancing or withdrawing the catheter through a stented vessel. Forcibly advancing or withdrawing the catheter may cause catheter entrapment, stent deformation, and/or stent dislocation.
  • Do not disconnect the Novasight Hybrid Catheter from the Novasight Hybrid PIM while the catheter is inserted in the patient. Doing so may expose the patient to the risk of electric shock.
  • Do not advance the Novasight Hybrid Catheter over the floppy end of a guidewire. This section of the guidewire may not support the Novasight Hybrid Catheter, which may result in kinking of the guidewire. If this occurs, stop imaging and carefully remove the guidewire and Novasight Hybrid Catheter together under fluoroscopic guidance. If resistance is felt, do not continue to withdraw the guidewire. Under fluoroscopic guidance, advance both the guidewire and Novasight Hybrid Catheter distally, and then remove the guidewire while holding the Novasight Hybrid Catheter stationary. Remove the Novasight Hybrid Catheter once the guidewire has been removed.
  • Conavi Medical does not support the use of the Novasight Hybrid Catheter for purposes other than those prescribed by the indications for use.
  • Do not modify any part of the Novasight Hybrid Catheter.
  • Never advance or withdraw the Novasight Hybrid Catheter within the coronary vasculature without using fluoroscopic guidance as this may lead to critical injury.
  • If the PIM bag tears, compromising the sterile field, discard the bag and replace with a new PIM bag.
  • The Hummingbird Console must only be connected to a supply mains with protective earth to achieve proper grounding and avoid the risk of electrical shock.
  • Failure to store the power cable as described in this manual may lead to degradation of the cable, causing possible patient or operator injury and damage to the system.
  • When adjusting the position of the monitors, avoid placing fingers near or around pinch point hazards.
  • Do not use a USB device connected to a separate power source as this may lead to electric shock.

Precautions:

  • Do not modify any part of the Novasight Hybrid System.
  • Use only accessories intended for use with the Novasight Hybrid System provided by Conavi Medical.
  • Medical instruments need to be installed in a manner that preserves the integrity of the Electromagnetic Compatibility (EMC) shielding. Unpacking of the Hummingbird Console and Novasight Hybrid PIM must be performed as instructed by Conavi Medical.
  • The Novasight Hybrid System may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as reorienting or relocating the equipment or shielding the location.
  • Do not use the Novasight Hybrid System in room equipped with a MRI System.
  • When reviewing acquired images, do not rely upon OCT-only image review for assessment of vessels possessing any of the following characteristics: <2.0mm in diameter, >3.5mm in diameter, left main coronary artery, or a target vessel that has undergone a previous bypass procedure.
  • The Novasight Hybrid Catheter is intended to be used intermittently to acquire images in the coronary arteries and should not be left in the coronary vasculature for prolonged periods of time.
  • Avoid handling the Novasight Hybrid Catheter in a manner that would create sharp bends in the catheter or kink the catheter.
  • Avoid advancing the Novasight Hybrid Catheter through the anatomy in a manner that would create sharp bends in the catheter or kink the catheter.
  • Do not use the Novasight Hybrid Catheter without first placing it onto a coronary guidewire.
  • Always retract the Novasight Hybrid Catheter from the hoop dispenser along a straight trajectory. Retracting the catheter along a bent trajectory may cause kinking.
  • Do not attempt to connect the Novasight Hybrid Catheter to electronic equipment other than the Novasight Hybrid PIM.
  • When flushing the Novasight Hybrid Catheter, do not use any fluid other than sterile saline to fill the syringes. Other fluids may impact image quality or catheter functionality.
  • Only use one hand to flush the syringe of saline into the Novasight Hybrid Catheter. Do not apply excessive pressure.
  • Do not use the Novasight Hybrid Catheter if you observe fluid leaking from any part of the catheter other than the vent port in the monorail section. If you notice fluid in the proximal connector or PIM bag and suspect that fluid may have entered the PIM, discontinue use of the PIM and contact Conavi Medical for further instructions.
  • Exercise care when handling the distal end of the Novasight Hybrid Catheter.
  • Do not submerge or store any portion of the Novasight Hybrid Catheter in fluid for prolonged periods of time. Doing so may impact deliverability and lead to catheter prolapse.
  • Do not eject the Novasight Hybrid Catheter from the Novasight Hybrid PIM while the catheter is inside the patient’s body.
  • If the Novasight Hybrid Catheter has crossed a deployed stent, care should be taken to prevent entanglement within the stent struts, especially if there is suspected stent malapposition at the distal edge of a stent. Use fluoroscopic guidance during advancement and retraction of the catheter to monitor the relative positions of guidewire, Novasight Hybrid Catheter, and stent. If resistance is felt at any time, stop imaging and carefully remove the guidewire and Novasight Hybrid Catheter together under fluoroscopic guidance. If this is not possible, hold the Novasight Hybrid Catheter stationary and remove the guidewire, followed by removing the catheter. If resistance persists, advance both the guidewire and Novasight Hybrid Catheter distal to the stent, and then remove the guidewire while holding the Novasight Hybrid Catheter stationary. Remove the Novasight Hybrid Catheter once the guidewire has been removed. Please note that the imaging core is preferably advanced to its most distal position during Novasight Hybrid Catheter retraction and advancement. This provides more rotational and longitudinal support for catheter deliverability.
  • Over-tightening the hemostatic valve may result in kinking of the catheter.
  • Before using the Novasight Hybrid PIM, visually inspect the unit to ensure it is free of any visible defects or signs of damage. If the PIM appears to be damaged, do not use the Novasight Hybrid System.
  • Check the integrity of the PIM cable prior to procedure to ensure there is no damage. If the PIM cable is compromised, do not use the Novasight Hybrid System.
  • If the Novasight Hybrid PIM becomes damaged at any time during the procedure, stop using the unit.
  • Do not place your finger or any other objects in the Novasight Hybrid PIM’s catheter connection port.
  • Prior to use, inspect the PIM cable for any signs of damage. If the PIM cable is compromised, do not use the Novasight Hybrid System.
  • Failure to store the PIM cable as described in this manual may lead to degradation of the cable, causing the ultrasound and/or optical signal to become compromised.
  • Only connect the Novasight Hybrid Catheter to the Novasight Hybrid PIM. Do not attempt to connect another manufacturer’s catheter to the PIM.
  • Prior to using the Hummingbird Console, inspect the unit’s power cable for signs of damage or exposed conductors. If the cable is compromised, do not use the Novasight Hybrid System.
  • Do not, under any circumstances, leave the Hummingbird Console on an incline of > 5 degrees (with or without the lock pedal engaged).
  • Wait four (4) minutes after powering down the Hummingbird Console before physically moving the unit to another location. This safeguards against potential damage to the console’s internal optical components.
  • To prevent the Hummingbird Console from tipping during transport, always ensure the wheels are unlocked before physically moving the unit.

Potential Adverse Effects:

The use of the Novasight Hybrid Catheter could result in adverse events, including, but not limited to:

  • Myocardial infarction
  • Occlusion
  • Coronary vessel dissection
  • Perforation, rupture, or injury
  • Hemorrhage or hematoma
  • Unstable angina
  • Arrhythmias
  • Drug reactions
  • Allergic reaction to contrast medium
  • Hypo/hypertension
  • Infection
  • Vessel spasm
  • Arteriovenous fistula
  • Embolism
  • Entry puncture site bleeding
  • Vascular wall injury
  • Vessel thrombosis
  • Pseudoaneurysm (at site of catheter insertion)
  • Renal failure
  • Coronary aneurysm
  • Vessel trauma requiring surgical repair or intervention
  • Catheter entrapment or stent deformation
  • Death

The Novasight Hybrid System is intended for intravascular imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Novasight Hybrid System is cleared for sale in the following jurisdictions (regulatory approvals referenced): • United States: FDA 510(k) clearance (K172258) • Canada: Health Canada medical device license (102500) • Japan: PMDA medical device license (catheter: 30200BZX00040000, console + PIM: 30200BZX00039000) Accessibility Policy: conavi.com/novasight/accessibility-policy