Dragonfly OpStar™ Imaging Catheter

Indications: The Dragonfly OpStar™ Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
 

Contraindications: Use of the Dragonfly OpStar™ Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

• Acute renal failure
• Bacteremia or sepsis
• Large thrombus
• Major coagulation system abnormalities
• Patients diagnosed with coronary artery spasm
• Patients disqualified for coronary artery bypass graft (CABG) surgery
• Patients disqualified for percutaneous transluminal coronary angioplasty (PTCA)
• Severe hemodynamic instability or shock
• Total occlusion
• Inability to tolerate systemic anticoagulation is a contraindication to use of OCT for coronary imaging

Warnings:

• Appropriate anticoagulant and vasodilator therapy is recommended to be used during the procedure as ordered by the physician.
• The Dragonfly OpStar™ Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Nonpyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize. Any attempt to reuse or re-sterilize may compromise the structural integrity of this device. Adverse effects of using a non-sterile or re-sterilized imaging catheter may include, but are not limited to:
  • Local and/or systemic infection
  • Mechanical damage
  • Inaccurate results
• Note the product "Use by" date on the package.
• Observe all advancement and movement of the Dragonfly OpStar™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly and ensure that the guide wire is coaxial to the monorail. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To ensure proper placement, do not move the guide wire after the Dragonfly OpStar™ Imaging Catheter is in place.
• If resistance is encountered during withdrawal of the Dragonfly OpStar™ Imaging Catheter:
  • Stop manipulation and evaluate under fluoroscopy.
  • If guide wire prolapse is observed, readvance the catheter, ensure the guide wire is coaxial - to the monorail, and reattempt withdrawal.
  • If the cause of resistance cannot be determined or mitigated, carefully remove the Dragonfly OpStar™ Imaging Catheter and guide wire as a unit from the patient and replace the Dragonfly OpStar™ Imaging Catheter and guide wire. Do not reuse the Dragonfly OpStar™ Imaging Catheter and guide wire.
• Leave the guide wire engaged with the Dragonfly OpStar™ Imaging Catheter at all times during use. Do not retract or advance the guide wire prior to withdrawing the Dragonfly OpStar™ Imaging Catheter.
• The Dragonfly OpStar™ Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
• The Dragonfly OpStar™ Imaging Catheter should not be advanced through abnormally tortuous anatomy.
• When advancing or retracting a Dragonfly OpStar™ Imaging Catheter with a monorail tip through a stented vessel, the Dragonfly imaging catheter may engage the stent between the junction of the Dragonfly OpStar™ Imaging Catheter and guide wire, resulting in entrapment of the catheter/guide wire, catheter tip separation, stent dislocation and/or vascular injury.
• Do not remove the Dragonfly OpStar™ Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.
• Always verify that the Dragonfly OpStar™ Imaging Catheter has been properly prepared prior to inserting into vasculature.
• The safety and effectiveness of the coated device has not been established, or is unknown, in vascular regions other than those specifically indicated.
• Failure to abide by the warnings in this Instructions for Use might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
   

Precautions:

• Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 mm to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
• Use the minimum flush rate and volume required to image the desired anatomy.
• For optimal imaging, only use 100% contrast media.
• Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.
• Do not kink, sharply bend, pinch, or crush the Dragonfly OpStar™ Imaging Catheter at any time.
• The Dragonfly OpStar™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the Dragonfly OpStar™ Imaging Catheter assembly as provided.
• After use, the Dragonfly OpStar™ Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
• When using saline, heparinized saline is recommended. When wet, the hydrophilic coating increases the lubricity of the coated surface.
• Avoid abrasion of the hydrophilic coating. Use caution when manipulating, advancing and / or withdrawing these devices through needles, metal cannulas, stents, or other devices with sharp edges, or through tortuous or calcified blood vessels. Manipulation, advancement, and / or withdrawal past sharp or beveled edges may result in destruction and / or separation of the outer coating, which may lead to clinical adverse events, resulting in coating material remaining in the vasculature or device damage. This may result in adverse events requiring additional intervention.
• The integrity and performance of the device coating can be negatively impacted by preparation with incompatible media or solvents. Please take note of the following important recommendations:
  • Avoid wiping the device with dry gauze as this may damage the device coating.
  • Avoid excessive wiping of the coated device.
  • Avoid using alcohol, antiseptic solutions, or other solvents to pre-treat the device because this may cause unpredictable changes in the coating which could negatively affect the safety and performance of the catheter.
• Do not soak the device as it may adversely impact the hydrophilic coating on the catheter.
• The Dragonfly OpStar™ Imaging Catheter must be purged prior to connection to the DOC to prevent damage to the imaging core.
• Ensure that the Dragonfly OpStar™ Imaging Catheter tip marker has been properly identified and differentiated from the lens marker before contrast administration and prior to performing the OCT reading.
• Never attempt to attach or detach the Dragonfly OpStar™ Imaging Catheter to the DOC while the "lock" LED is lit.

Complications:

The following complications may occur as a consequence of intravascular imaging and catheterization procedure:

• Allergic reaction to the contrast media or drug administered for the procedure
• Bleeding
• Arterial dissection, injury or perforation
• Abnormal heart rhythm or arrhythmias
• Unstable angina
• Coronary artery spasm
• Thrombus formation, abrupt closure, or total occlusion
• Embolism
• Infection
• Myocardial ischemia
• Acute myocardial infarction
• Repeat revascularization
• Renal insufficiency or failure from contrast media use
• Death
• Catheter access side reactions: inflammation or granuloma or tissue necrosis
• Hypotension