Indications, Safety, and Warnings
Aristotle® 14 Guidewire
Caution Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use The Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Contraindications None known.
Compatibility Minimum Microcatheter ID: 0.0165” (0.42mm)
Potential Complications Potential complications include, but are not limited to: aneurysm perforation / rupture, death, embolus, infarct, hemorrhage, infection, ischemia, neurological / intracranial sequelae, pseudoaneurysm, stroke, transient ischemic attack, vasospasm, vessel trauma / occlusion / perforation / dissection, tissue necrosis, other procedural complications including, but not limited to, anesthetic and contrast media risks, hemodynamic compromise, renal insufficiency, sterile inflammation or granulomas at access site and access site complications.
This device requires the use with fluoroscopy. Potential complications related to angiographic and fluoroscopic X-ray radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. The probability of occurrence of complications may increase as procedure time and number of procedures increase.
Warnings and Precautions
This guidewire should be used only by physicians trained in percutaneous interventional techniques and procedures.
Inspect the guidewire prior to use for any damage such as kinks or bends. Do not use a damaged guidewire. Any guidewire damage may decrease performance resulting in patient injury or death.
Aristotle 14 Guidewires are not safe for use in or near Magnetic Resonance Imaging (MRI) equipment.
The Aristotle 14 Guidewire is supplied STERILE for single use only. Do not use if sterile barrier is damaged or package is opened.
This device is intended for single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or resterilizing may compromise device integrity and/or performance and may lead to device failure resulting in patient injury, illness, or death. Reuse, reprocessing or resterilizing also increases the risk of contamination and / or patient infection or cross-infection including, but not limited to, transmission of infectious disease(s) resulting in patient injury, illness, or death.
The plastic introducer, the metal shaping mandrel and the torque device are included to aid the use of the guidewire and are not intended to enter the patient’s body.
Use the guidewire prior to the “Use By” date specified on the package.
Avoid wiping the device with dry gauze as this may damage the device coating.
Avoid excessive wiping of the hydrated 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 affect the device safety and performance.
The Aristotle 14 Guidewire should be manipulated under fluoroscopy. Do not attempt to move the guidewire without observing the resulting tip response. Advance and withdraw the guidewire slowly and carefully. Never advance or withdraw the guidewire against resistance that is felt or observed under fluoroscopy until the cause of the resistance is determined. Movement of the guidewire against resistance may result in damage to the guidewire or injury to the patient.
Confirm the compatibility of the guidewire and other devices being used in the procedure.
Securely fasten the torque device onto the guidewire during use to prevent the torque device from slipping and damaging the guidewire and/or its coating.
Maintain a constant saline flush between the catheter and the guidewire during a procedure.
Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
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.
Additional Warnings
Prior to using an interventional device with the Aristotle 14 Guidewire, review the device’s labeling for the intended use, contraindications, potential complications, warnings, and precautions of the device.
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.
Use fluoroscopy to monitor guidewire movement. Be sure to observe distal tip movement whenever the proximal portion is moved or rotated. Always advance, retract, or rotate the guidewire slowly and carefully.
US-NEU-2600485 (v1.0)
===============================
Zoom Wire™ 14 Guidewire
Caution Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use The Zoom Wire 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Contraindications None known.
Compatibility Minimum Microcatheter ID: 0.0165” (0.42mm)
Potential Complications Potential complications include, but are not limited to: aneurysm perforation / rupture, death, embolus, infarct, hemorrhage, infection, ischemia, neurological / intracranial sequelae, pseudoaneurysm, stroke, transient ischemic attack, vasospasm, vessel trauma / occlusion / perforation / dissection, tissue necrosis, other procedural complications including, but not limited to, anesthetic and contrast media risks, hemodynamic compromise, renal insufficiency, sterile inflammation or granulomas at access site and access site complications.
This device requires the use with fluoroscopy. Potential complications related to angiographic and fluoroscopic X-ray radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. The probability of occurrence of complications may increase as procedure time and number of procedures increase.
Warnings and Precautions
This guidewire should be used only by physicians trained in percutaneous interventional techniques and procedures.
Inspect the guidewire prior to use for any damage such as kinks or bends. Do not use a damaged guidewire. Any guidewire damage may decrease performance resulting in patient injury or death.
Zoom Wire 14 Guidewires are not safe for use in or near Magnetic Resonance Imaging (MRI) equipment.
The Zoom Wire 14 Guidewire is supplied STERILE for single use only. Do not use if sterile barrier is damaged or package is opened.
This device is intended for single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or resterilizing may compromise device integrity and/or performance and may lead to device failure resulting in patient injury, illness, or death. Reuse, reprocessing or resterilizing also increases the risk of contamination and / or patient infection or cross-infection including, but not limited to, transmission of infectious disease(s) resulting in patient injury, illness, or death.
The plastic introducer, the metal shaping mandrel and the torque device are included to aid the use of the guidewire and are not intended to enter the patient’s body.
Use the guidewire prior to the “Use By” date specified on the package.
Avoid wiping the device with dry gauze as this may damage the device coating.
Avoid excessive wiping of the hydrated 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 affect the device safety and performance.
The Zoom Wire 14 Guidewire should be manipulated under fluoroscopy. Do not attempt to move the guidewire without observing the resulting tip response. Advance and withdraw the guidewire slowly and carefully. Never advance or withdraw the guidewire against resistance that is felt or observed under fluoroscopy until the cause of the resistance is determined. Movement of the guidewire against resistance may result in damage to the guidewire or injury to the patient.
Confirm the compatibility of the guidewire and other devices being used in the procedure.
Securely fasten the torque device onto the guidewire during use to prevent the torque device from slipping and damaging the guidewire and/or its coating.
Maintain a constant saline flush between the catheter and the guidewire during a procedure.
Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
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.
Additional Warnings
Prior to using an interventional device with the Zoom Wire 14 Guidewire, review the device’s labeling for the intended use, contraindications, potential complications, warnings, and precautions of the device.
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.
Use fluoroscopy to monitor guidewire movement. Be sure to observe distal tip movement whenever the proximal portion is moved or rotated. Always advance, retract, or rotate the guidewire slowly and carefully.
US-NEU-2600493 (v1.0)
===============================
Aristotle® 18 Guidewire
Caution Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Contraindications None known.
Compatibility Minimum Microcatheter ID: 0.021” (0.53mm)
Potential Complications Potential complications include, but are not limited to: aneurysm perforation / rupture, death, embolus, infarct, hemorrhage, infection, ischemia, neurological / intracranial sequelae, pseudoaneurysm, stroke, transient ischemic attack, vasospasm, vessel trauma / occlusion / perforation / dissection, tissue necrosis, other procedural complications including, but not limited to, anesthetic and contrast media risks, hemodynamic compromise, renal insufficiency, sterile inflammation or granulomas at access site and access site complications.
This device requires the use with fluoroscopy. Potential complications related to angiographic and fluoroscopic X-ray radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. The probability of occurrence of complications may increase as procedure time and number of procedures increase.
Warnings and Precautions
This guidewire should be used only by physicians trained in percutaneous interventional techniques and procedures.
Inspect the guidewire prior to use for any damage such as kinks or bends. Do not use a damaged guidewire. Any guidewire damage may decrease performance resulting in patient injury or death.
Aristotle 18 Guidewires are not safe for use in or near Magnetic Resonance Imaging (MRI) equipment.
The Aristotle 18 Guidewire is supplied STERILE for single use only. Do not use if sterile barrier is damaged or package is opened.
This device is intended for single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or resterilizing may compromise device integrity and/or performance and may lead to device failure resulting in patient injury, illness, or death. Reuse, reprocessing or resterilizing also increases the risk of contamination and / or patient infection or cross-infection including, but not limited to, transmission of infectious disease(s) resulting in patient injury, illness, or death.
The plastic introducer, the shaping mandrel and the torque device are included to aid the use of the guidewire and are not intended to enter the patient’s body.
Use the guidewire prior to the “Use By” date specified on the package.
Avoid wiping the device with dry gauze as this may damage the device coating.
Avoid excessive wiping of the hydrated 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 affect the device safety and performance.
The Aristotle 18 Guidewire should be manipulated under fluoroscopy. Do not attempt to move the guidewire without observing the resulting tip response. Advance and withdraw the guidewire slowly and carefully. Never advance or withdraw the guidewire against resistance that is felt or observed under fluoroscopy until the cause of the resistance is determined. Movement of the guidewire against resistance may result in damage to the guidewire or injury to the patient.
Confirm the compatibility of the guidewire and other devices being used in the procedure.
Securely fasten the torque device onto the guidewire during use to prevent the torque device from slipping and damaging the guidewire and/or its coating.
Maintain a constant saline flush between the catheter and the guidewire during a procedure.
Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
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.
Additional Warnings
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.
Use fluoroscopy to monitor guidewire movement. Be sure to observe distal tip movement whenever the proximal portion is moved or rotated. Always advance, retract, or rotate the guidewire slowly and carefully.
US-NEU-2600486 (v1.0)
===============================
Aristotle® 24 Guidewire
Caution Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Contraindications None known.
Compatibility Minimum Microcatheter ID: 0.027” (0.69mm)
Potential Complications Potential complications include, but are not limited to: aneurysm perforation / rupture, death, embolus, infarct, hemorrhage, infection, ischemia, neurological / intracranial sequelae, pseudoaneurysm, stroke, transient ischemic attack, vasospasm, vessel trauma / occlusion / perforation / dissection, tissue necrosis, other procedural complications including, but not limited to, anesthetic and contrast media risks, hemodynamic compromise, renal insufficiency, sterile inflammation or granulomas at access site and access site complications.
This device requires the use with fluoroscopy. Potential complications related to angiographic and fluoroscopic X-ray radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. The probability of occurrence of complications may increase as procedure time and number of procedures increase.
Warnings and Precautions
This guidewire should be used only by physicians trained in percutaneous interventional techniques and procedures.
Inspect the guidewire prior to use for any damage such as kinks or bends. Do not use a damaged guidewire. Any guidewire damage may decrease performance resulting in patient injury or death.
Aristotle 24 Guidewires are not safe for use in or near Magnetic Resonance Imaging (MRI) equipment.
The Aristotle 24 Guidewire is supplied STERILE for single use only. Do not use if sterile barrier is damaged or package is opened.
This device is intended for single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or resterilizing may compromise device integrity and/or performance and may lead to device failure resulting in patient injury, illness, or death. Reuse, reprocessing or resterilizing also increases the risk of contamination and / or patient infection or cross-infection including, but not limited to, transmission of infectious disease(s) resulting in patient injury, illness, or death.
The plastic introducer, the shaping mandrel and the torque device are included to aid the use of the guidewire and are not intended to enter the patient’s body.
Use the guidewire prior to the “Use By” date specified on the package.
Avoid wiping the device with dry gauze as this may damage the device coating.
Avoid excessive wiping of the hydrated 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 affect the device safety and performance.
The Aristotle 24 Guidewire should be manipulated under fluoroscopy. Do not attempt to move the guidewire without observing the resulting tip response. Advance and withdraw the guidewire slowly and carefully. Never advance or withdraw the guidewire against resistance that is felt or observed under fluoroscopy until the cause of the resistance is determined. Movement of the guidewire against resistance may result in damage to the guidewire or injury to the patient.
Confirm the compatibility of the guidewire and other devices being used in the procedure.
Securely fasten the torque device onto the guidewire during use to prevent the torque device from slipping and damaging the guidewire and/or its coating.
Maintain a constant saline flush between the catheter and the guidewire during a procedure.
Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
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.
Additional Warnings
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.
Use fluoroscopy to monitor guidewire movement. Be sure to observe distal tip movement whenever the proximal portion is moved or rotated. Always advance, retract, or rotate the guidewire slowly and carefully.
US-NEU-2600487 (v1.0)
===============================
Aristotle® Colossus Guidewire
Caution Federal law (USA) restricts this device to sale by or on the order of a physician.
Indications for Use The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.
Contraindications None known.
Compatibility Minimum Catheter ID: 0.038” (0.97mm)
Potential Complications Potential complications include, but are not limited to: aneurysm perforation / rupture, death, embolus, infarct, hemorrhage, infection, ischemia, neurological / intracranial sequelae, pseudoaneurysm, stroke, transient ischemic attack, vasospasm, vessel trauma / occlusion / perforation / dissection, tissue necrosis, other procedural complications including, but not limited to, anesthetic and contrast media risks, hemodynamic compromise, renal insufficiency, sterile inflammation or granulomas at access site and access site complications.
This device requires the use with fluoroscopy. Potential complications related to angiographic and fluoroscopic X-ray radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia. The probability of occurrence of complications may increase as procedure time and number of procedures increase.
Warnings and Precautions
This guidewire should be used only by physicians trained in percutaneous interventional techniques and procedures.
Inspect the guidewire prior to use for any damage such as kinks or bends. Do not use a damaged guidewire. Any guidewire damage may decrease performance resulting in patient injury or death.
Aristotle Colossus Guidewires are not safe for use in or near Magnetic Resonance Imaging (MRI) equipment.
The Aristotle Colossus Guidewire is supplied STERILE for single use only. Do not use if sterile barrier is damaged or package is opened.
This device is intended for single use only. Do not reuse, reprocess or re-sterilize. Reuse, reprocessing or resterilizing may compromise device integrity and/or performance and may lead to device failure resulting in patient injury, illness, or death. Reuse, reprocessing or resterilizing also increases the risk of contamination and / or patient infection or cross-infection including, but not limited to, transmission of infectious disease(s) resulting in patient injury, illness, or death.
The plastic introducer, the shaping mandrel and the torque device are included to aid the use of the guidewire and are not intended to enter the patient’s body.
Use the guidewire prior to the “Use By” date specified on the package.
Avoid wiping the device with dry gauze as this may damage the device coating.
Avoid excessive wiping of the hydrated 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 affect the device safety and performance.
The Aristotle Colossus Guidewire should be manipulated under fluoroscopy. Do not attempt to move the guidewire without observing the resulting tip response. Advance and withdraw the guidewire slowly and carefully. Never advance or withdraw the guidewire against resistance that is felt or observed under fluoroscopy until the cause of the resistance is determined. Movement of the guidewire against resistance may result in damage to the guidewire or injury to the patient.
Confirm the compatibility of the guidewire and other devices being used in the procedure.
Securely fasten the torque device onto the guidewire during use to prevent the torque device from slipping and damaging the guidewire and/or its coating.
Maintain a constant saline flush between the catheter and the guidewire during a procedure.
Limit the exposure to X-ray radiation doses to patients and physicians by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors when possible.
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.
Additional Warnings
Do not use this device with catheters below an ID of 0.038” (0.97mm) as damage to guidewire hydrophilic coating may occur.
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.
Use fluoroscopy to monitor guidewire movement. Be sure to observe distal tip movement whenever the proximal portion is moved or rotated. Always advance, retract, or rotate the guidewire slowly and carefully.
US-NEU-2600488 (v1.0)
