Proceed in engaging and navigating through complex lesions.3
|Product||Part Number||Diameter||Length||Tip Load||Tip Style||Units Per Package|
|Hi-Torque Proceed™, 170T, Angled||1030901||0.014 in||190 cm||11 g||Core-to-Tip||5|
|Hi-Torque Proceed™, 170T, Angled||1030902||0.014 in||300 cm||11 g||Core-to-Tip||5|
|Hi-Torque Proceed™, 220T, Angled||1030903||0.014 in||190 cm||14 g||Core-to-Tip||5|
|Hi-Torque Proceed™, 220T, Angled||1030904||0.014 in||300 cm||14 g||Core-to-Tip||5|
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal angioplasty (PTA), in arteries such as the femoral, popliteal, and infrapopliteal arteries. This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Not intended for use in the cerebral vasculature.
This device is not designed for use with atherectomy devices. The safety and effectiveness of the use of this Hi-Torque™ Guide Wire with atherectomy devices are unestablished.
The lifetime of this device is the labeled shelf life. This device is designed and intended for ONE-TIME USE ONLY. Do not resterilize and / or reuse. The safety and effectiveness of this device have not been established after being reprocessed for multiple uses.
This device has a hydrophilic coating at the distal end of the device for a length of 25.6 cm, and a silicone based hydrophobic coating at the proximal end for a length of 133 cm (on 190 cm wires) and 250 cm (on 300 cm wires), and a polytetrafluoroethylene (PTFE) hydrophobic coating at the proximal end for a length of 156.5 cm (on 190 cm wires) and 266.5 cm (on 300 cm wires).
Please refer to section PREPARATION FOR USE for further information on how to prepare and use this device to ensure it performs as intended. Failure to abide by the warnings in this labeling might result in damage to the device coating, which may necessitate intervention or result in serious adverse events.
Use extreme caution and careful judgement in patients for whom anticoagulation is not indicated.
If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
The safety and effectiveness of this device have not been established, or is unknown, in vascular regions other than those specifically indicated.
This device contains stainless steel, platinum-nickel alloy, tin-silver alloy, gold-tin alloy, Microglide™ silicone coating, PTFE coating, polyvinylpyrrolidone (PVP) coating that may cause allergic or hypersensitivity reactions. Persons allergic to these may suffer an allergic reaction to this guide wire. Prior to its use on the patient, the patient should be counseled on the materials contained in the device, and a thorough history of allergies must be discussed.
Guide wires are delicate instruments and should be handled carefully. Prior to use and when possible during the procedure, inspect the guide wire carefully for bends, kinks, or other damage. Do not use damaged guide wires. Using a damaged guide wire may result in vessel damage and / or inaccurate torque response.
Confirm the compatibility of the guide wire diameter with the interventional device before actual use.
Please refer to the indication on the label and the Instructions for Use to confirm the appropriate vasculature that this guide wire may be used in. Failure to abide by the above recommendation may result in size mismatch of blood vessel and guide wire, which can result in vessel injury, such as, but not limited to, perforation, dissection, rupture, and avulsion.
Free movement of the guide wire within the interventional device is an important feature of a steerable guide wire system, because it gives the user valuable tactile information. Test the system for any resistance prior to use. Adjust or replace the hemostatic valve with an adjustable valve if it is found to inhibit guide wire movement. It is recommended that the user determine the source of resistance, exercise caution when removing the device and / or other components as a unit, and exchange the device for a new one to complete the procedure.
Never attach the torque device to the modified portion of the proximal end of the extendible guide wire; otherwise, guide wire damage may occur, preventing the ability to attach the DOC™ Guide Wire Extension.
Avoid abrasion of the hydrophilic coating. Do not withdraw or manipulate the hydrophilic-coated wire through a metal cannula or sharp-edged object. Manipulation, advancement, and / or withdrawal through a metal device may result in destruction and / or separation of the outer coating, which may cause coating material to remain in the vasculature. This in turn may lead to unintended adverse events requiring additional intervention.
After use, this product may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.
CAUTION: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
When wet, a hydrophilic coating increases the lubricity of the guide wire surface.
Do not soak the device for longer than 4 hours when the device is not in use. Avoid pre-soaking devices for longer than instructed, as this may impact the coating performance.
Percutaneous transluminal angioplasty (PTA) should only be performed at centers where emergency peripheral artery bypass surgery is available.
This guide wire family has distal ends of varying stiffness. Operate these guide wires carefully so as to not injure the blood vessels, observing the information in these instructions. The higher torque performance, stiffer distal ends, and / or higher advancement force may present a higher risk of perforation or injury than a guide wire with a more pliable distal end. Therefore, use the guide wire with the least stiff distal end that will treat the lesion, and use extreme care to minimize the risk of perforation or other damage to blood vessels.
The coating swells when exposed to aqueous media, but does not have any impact on device use.
The user and / or patient should report any serious incident that has occurred in relation to the Hi-Torque Proceed™ Guide Wire to the manufacturer and the competent authority of the European Member State in which the user and / or patient is established.
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:
Attempting to alter the shape of devices by bending, twisting, or similar methods beyond instructed methods may compromise the coating integrity, and that damage to the coating may not always be noticeable to the naked eye.
Potential adverse events associated with use of this device may include the following but are not limited to: