Coronary Microvascular Dysfunction

INDICATIONS

The PressureWire™ X Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the heart and in the coronary and peripheral blood vessels. Physiological parameters include blood pressure. The PressureWire™ X Guidewire can also measure blood temperature.

CONTRAINDICATIONS

This guidewire is contraindicated for use in the cerebral vasculature.

POTENTIAL ADVERSE EVENTS               

Potential adverse events which may be encountered during all catheterization procedures include, but are not limited to:

• Bleeding 

• Hypotension / hypertension 

• Chest pain 

• Coronary / peripheral vascular injury 
  • Vascular dissection  
  • Perforation of vessels  
  • Stenosis  
  • Pseudoaneurysm 

• Vasoconstriction 

• Myocardial ischemia, tissue hypoxia 

• Myocardial infarction 

• Organ injury 

• Thrombosis 

• Death 

• Arrhythmias 

• Cardiac tamponade / pericardial effusion 

• Bronchospasm (adenosine related) 

• Prolonged procedure 

• Foreign body in patient 

• Urgent revascularization 

• Congestive heart failure 

• Embolus 

• Local and / or systemic infection 

• Device failures  

• Hypersensitivity/ allergic reaction to device materials, medications or contrast 

In addition, this device has a coating containing Polyethylene Glycol (PEG); potential allergic reactions (anaphylaxis) may occur during the interventional procedure of the patient is allergic to PEG.

WARNINGS

• The PressureWire™ X Guidewire must not be modified in any way by the customer. Making modifications may interfere with correct operation and will void product warranties. See your Abbott Technical Service representative for more information.
• Note the product “Use-by-date” on the package.
• The PressureWire™ X Guidewire is supplied sterile. Discard the guidewire if the pouch is opened or damaged, compromising the sterile barrier. The guidewire is designed for single use only and shall not be reused or resterilized. Adverse effects of using a non-sterile or resterilized guidewire may include, but are not limited to:
  • Local and / or systemic infection
  • Mechanical damage
  • Inaccurate readings
• Observe all guidewire movements. Whenever the guidewire is moved or torqued, the tip movement should be examined under fluoroscopy. Never push, withdraw,
  or torque the guidewire if it meets resistance or without observing corresponding movement of the tip; otherwise vessel/ventricle trauma may occur.
• Torquing or excessive manipulation of the guidewire in a sharp bend, against resistance, or repeated attempts to cross a total vessel occlusion may:
  • Cause dissection or perforation of blood vessels
  • Cause vessel spasm
  • Damage and / or fracture the guidewire
• When introducing the guidewire, flush the catheter and administer anticoagulation as for a standard catheterization procedure or clotting may occur.
• Do not use the guidewire in the ventricles if the patient has a prosthetic mechanical or biological valve. It may result in damage to both the prosthesis and the guidewire, which may cause injury or death.
• Use of the PressureWire™ X Guidewire in conjunction with interventional devices with a short rapid exchange may result in a folded or fractured guidewire.
• High frequency surgical devices must not be used on a patient at the same time as the guidewire.
• The safety and effectiveness of the coated device have not been established, or are 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.

CAUTIONS

• The PressureWire™ X Guidewire is a delicate instrument and should be handled carefully.
• Make sure that the PressureWire™ X Guidewire transmitter is kept dry to ensure accurate pressure and/or temperature readings. Inaccurate readings or a wet transmitter may necessitate device replacement.
• Do not use the PressureWire™ X Guidewire in conjunction with atherectomy catheters. It may damage the PressureWire™ X Guidewire.
• Do not withdraw or manipulate the PressureWire™ X Guidewire with a sharp-edged object. It may result in abrasion of the PressureWire™ X Guidewire coating. When wet, the hydrophilic coating increases the lubricity of the coated surface.
• Factors that may affect the accuracy of the diagnostic information include, but are not limited to:
  • Improper placement of the aortic pressure sensor.
  • Failure to achieve maximum coronary and myocardial hyperemia in FFR procedures
  • Blood flow affected by the position of interventional devices, such as balloon catheters.
•  PressureWire™ X Guidewire readings may be affected by defibrillation. Rezero the guidewire after defibrillation use.
• Do not measure pressure when the PressureWire™ X Guidewire sensor element is in a sharp bend or in contact with atrial or ventricular walls. It might result in pressure artifacts.
• Do not use the PressureWire™ X Guidewire together with another guidewire, for so called jailed wire technique, due to difficulty in guidewire withdrawal and possible guidewire entrapment.
• Avoid abrasion of the distal hydrophilic and proximal PTFE coating regions. 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 distal end of the device with dry gauze as this may damage the device coating; refer to Directions for Use for removal / reintroduction instructions.
  • 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 device.
  • Do not soak the device as it may adversely impact the hydrophilic coating on the device.
• The PressureWire™ X Guidewire contains parts with > 0.1% w/w concentration of 1-methyl-2-pyrrolidone or NMP, which has shown reproductive toxicity and teratogenicity in animal tests. This device has not been tested in pregnant women or in men intending to father children. Effects on the developing fetus have not been studied. In the worst-case scenario, the amount of NMP that may elute out of the PressureWire™ X Guidewire is > 25 times lower than the permissible daily exposure (PDE) by the ICH Q3C (R8) Guidelines for Residual Solvents. Occurrence of this worst-case scenario is highly unlikely, and the expected exposure time of the patient for the FFR procedure is 60 minutes. While there is no contraindication, the risks and reproductive effects of use of this device on humans are unknown at this time, It is recommended that the need of the patient and the clinical benefit of FFR be weighed against the risk stated above.
• One or more components of this device may contain the following substances defined as CMR 18 in a concentration above 0.1% weight by weight: Cobalt; Chemical Abstracts Service (CAS) No. 7440-48-4; EC No. 231-158-0. Current scientific evidence supports that medical devices manufactured from stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.
• The safety and effectiveness of the PressureWire™ X Guidewire has not been established in the pediatric population.
• Persons with known history of allergies to any of the components of this device listed below may suffer an allergic reaction to this device. Prior to its use on the patient, the patient should be counseled on the material contained in the device, and a thorough history of allergies must be discussed. This device contains:
  • Epoxy adhesive
  • Gold
  • Palladium-iridium alloy
  • Polyethylene glycol
  • Polyimide
  • Polyvinyl pyrrolidone hydrophilic coating
  • Polytetrafluoroethylene coating
  • Silicone
  • Silicon
  • Silicon nitride
  • Stainless steel
  • Tin solder paste
• Store at room temperature (15°C to 25°C) in a dry and dark place.