AngioJet™ Thrombectomy Systems indications, safety and warnings

The AngioJet Solent Dista Thrombectomy Set is intended for use with the AngioJet Console to break apart and remove thrombus from:

• upper and lower extremity peripheral arteries and
• for use with the AngioJet Power Pulse technique for the control and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system.

Do not use the Thrombectomy Set in patients:

• who are contraindicated for endovascular procedures
• in whom the lesion cannot be accessed with a guidewire
• who cannot tolerate contrast media

• Refer to the AngioJet Console Operator’s Manual for other warnings, precautions, and system setup instructions.
• The Thrombectomy Set has not been evaluated for treatment of pulmonary embolism. There are reports of serious adverse events, including death, associated with cases where the Thrombectomy Set was used in treatment of pulmonary embolism.
• The Thrombectomy Set has not been evaluated for use in the carotid or cerebral vasculature.
• The Thrombectomy Set has not been evaluated for use in the coronary vasculature.
• Operation of the Catheter may cause embolism and/or vessel occlusion.
• Cardiac arrhythmias during Catheter operation have been reported in a small number of patients. Cardiac rhythm should be monitored during Catheter use and appropriate management, such as temporary pacing, can be employed, if needed.
• Do not use the AngioJet System in patients who have an injury in the target vessel to avoid further vessel trauma or hemorrhage.
• Do not use the Thrombectomy Set in vessels smaller than the minimum vessel diameter as listed in Table 1; such use may increase risk of vessel trauma.
• In addition to the heparin added to the saline supply bag, systemic heparinization is advisable to avoid thrombosis.
• Use of the Thrombectomy Set may result in hemolysis which should be monitored to manage possible renal, pancreatic, or other adverse events. Table 2 lists maximum recommended operating times for the procedure. Evaluate the patient’s risk tolerance for hemolysis (such as body size, thrombus burden, and renal function) prior to the procedure. Consider appropriate hydration prior to, during, and after the procedure.
• Obstructed lesions that are difficult to cross with the catheter to access thrombus may be balloon-dilated with low pressure (≤2 atm). Failure to pre-dilate difficult-to-cross lesions prior to catheter operation may result in vessel trauma.
• Monitor thrombotic debris/fluid flow exiting the Thrombectomy Set via the waste tubing during use. If blood is not visible in the waste tubing while the AngioJet System is activated in Thrombectomy Mode, the catheter may be occlusive within the vessel; verify catheter position, vessel diameter, and thrombus status. Operation under occlusive conditions may increase risk of vessel trauma.

• Use the Thrombectomy Set only with the AngioJet Console.
• Verify “Use By” date printed on the product label has not expired. Do not use the Thrombectomy Set if “Use By” date has expired, as sterility or function may be compromised.
• Visually inspect the Thrombectomy Set prior to use to ensure that no damage has occurred during shipment. Do not use a damaged Thrombectomy Set for patient treatment.
• Do not attempt to straighten or use the Thrombectomy Set if it is bent or kinked. Attempting to do so may result in catheter rupture.
• Prime the Thrombectomy Set outside the patient; priming inside the patient may lead to embolism.
• After priming, do not operate the catheter without a guidewire in place as this will affect System performance.
• Do not exceed the wire compatibility listed in Table 1. Attempting to use a larger guidewire will damage the catheter and the guidewire.
• If resistance is felt during the advancement of the Thrombectomy Set to the lesion site, do not force or torque the catheter excessively. This may result in deformation of the tip components which may degrade catheter performance.
• Do not pull the catheter against abnormal resistance. If increased resistance is felt when withdrawing the catheter, remove the catheter together with the sheath or guide catheter as a unit to prevent possible catheter damage or separation.
• Do not exchange the guidewire. Do not retract the guidewire into the catheter during operation. If retraction of the guidewire into the catheter occurs, it may be necessary to remove both the catheter and the guidewire from the patient in order to reload the catheter over the guidewire.

Potential adverse events which may be associated with use of the AngioJet Thrombectomy System when used as indicated include, but are not limited to:

• Allergic reaction (to drug, contrast, device or other)
• Aneurysm
• Arrhythmia
• Bleeding/hemorrhage
• Cerebrovascular accident (CVA), transient ischemic attack (TIA)
• Death
• Electric shock
• Embolism (air, plaque, thrombus, device or other)
• Hematoma
• Hemolysis
• Hypotension/hypertension
• Infection/sepsis
• Myocardial ischemia/infarction
• Need for additional intervention or surgery
• Pain
• Pancreatitis
• Renal insufficiency/failure
• Thrombus/thrombosis
• Vasospasm
• Vessel occlusion
• Vessel trauma (dissection, injury, perforation, pseudoaneurysm, rupture)

92292207 C

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The AngioJet Ultra Console is intended to be used with the AngioJet Thrombectomy Sets for the percutaneous removal of thrombus in the treatment of vascular disease.

The AngioJet Ultra Console is intended for use only in conjunction with an AngioJet Thrombectomy Set. Refer to the individual Thrombectomy Set Instructions for Use for specific clinical applications.

Refer to the individual Thrombectomy Set Instructions for Use for specific contraindications.

• Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide.
• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• Do not attempt to bypass any of the Console safety features.
• The AngioJet Ultra System should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the Console should be observed to verify normal operation in the configuration in which it will be used.
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the AngioJet Ultra System, including cables  specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
• Use of accessories, transducers, and cables other than those specified or provided by Boston Scientific could result in increased electromagnetic emissions or decreased electromagnetic immunity of the AngioJet Ultra  System and result in improper operation.
• Removal of outer covers may resultin electrical shock.

• Use the AngioJet Ultra Console only with an AngioJet Thrombectomy Set.
• The AngioJet Ultra System requires special precautions regarding electromagnetic emissions and immunity and needs to be installed and put into service according to the information included in the Electronic and Electromagnetic Guidance section.
• This device may cause electromagnetic interference with other devices when in use. Do not place the AngioJet Ultra System near sensitive equipment when operating.
• Visually inspect the Console prior to use. Use of a damaged Console is not recommended, as injury may occur.
• Console bag hooks are intended for physician-specified fluid and/or saline bags only. Hanging other objects or applying additional weight to the bag hooks may cause damage.
• When the drawer is extended from the Console, avoid knocking into or leaning on the drawer. This may damage the device.
• Prime the Thrombectomy Set outside the patient; priming inside the patient may lead to air embolism.
• Do not move the waste bag during catheter operation, as this may cause a waste tubing error. 
• Do not reposition or push the Console from any point other than the handle designed for that purpose. A condition of overbalance or tipping may ensue.
• In the event the foot switch is stuck in the “on” position (inadvertent activation), press the POWER button or pull the power cord from the wall outlet to deactivate the system. Contact Boston Scientific Customer Service.
• If it becomes necessary to replace the fuses, replace with the type and rating specified. Failure to do so may result in device damage or risk of fire.

Refer to the individual Thrombectomy Set Instructions for Use for specific observed and/or potential adverse events.

92292210 (D.3)

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The AngioJet ZelanteDVT Thrombectomy Set is intended for use with the AngioJet Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:

• Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and
• Upper extremity peripheral veins ≥ 6.0 mm in diameter.

The ZelanteDVT Thrombectomy Set is also intended for use with the AngioJet Power Pulse technique for the controlled and selective infusion of physician-specified fluids, including thrombolytic agents, into the peripheral vascular system.

• Do not use the ZelanteDVT Thrombectomy Set in patients who are contraindicated for endovascular procedures.
• Do not use the ZelanteDVT Thrombectomy Set in patients in whom the lesion cannot be accessed with a guidewire.
• Do not use the ZelanteDVT Thrombectomy Set in patients who cannot tolerate contrast media.

• Refer to the AngioJet Console Operator’s Manual for other warnings, precautions, and system setup instructions.
• The Thrombectomy Set has not been evaluated for treatment of pulmonary embolism. There are reports of serious adverse events, including death, associated with cases where the Thrombectomy Set was used in treatment of pulmonary embolism.
• The Thrombectomy Set has not been evaluated for use in the carotid or cerebral vasculature.
• The Thrombectomy Set has not been evaluated for use in the coronary vasculature.
• Operation of the Catheter may cause embolism and/or vessel occlusion.
• Cardiac arrhythmias during Catheter operation have been reported in a small number of patients. Cardiac rhythm should be monitored during Catheter use and appropriate management, such as temporary pacing, can be employed, if needed.
• Do not use the AngioJet System in patients who have an injury in the target vessel to avoid further vessel trauma or hemorrhage.
• Do not use the Thrombectomy Set in vessels smaller than the minimum vessel diameter as listed in Table 1; such use may increase risk of vessel trauma.
• In addition to the heparin added to the saline supply bag, systemic heparinization is advisable to avoid thrombosis.
• Use of the Thrombectomy Set may result in hemolysis which should be monitored to manage possible renal, pancreatic, or other adverse events. Table 2 lists maximum recommended operating times for the procedure. Evaluate the patient’s risk tolerance for hemolysis (such as body size, thrombus burden, and renal function) prior to the procedure. Consider appropriate hydration prior to, during, and after the procedure.
• Obstructed lesions that are difficult to cross with the catheter may be predilated with low pressure (≤ 2 atm). Failure to predilate difficult-to-cross lesions prior to catheter operation may result in vessel trauma.
• Monitor thrombotic debris/fluid flow exiting the Thrombectomy Set via the waste tubing during use. If blood is not visible in the waste tubing while the AngioJet System is activated in Thrombectomy Mode, the catheter may be occlusive within the vessel; verify catheter position, vessel diameter, and thrombus status. Operation under occlusive conditions may increase risk of vessel trauma.
• The potential for pulmonary thromboembolism should be carefully considered when the Thrombectomy Set is used to break up and remove peripheral venous thrombus.

• Use the Thrombectomy Set only with the AngioJet Console.
• Verify "Use By" date printed on the product label has not expired. Do not use the Thrombectomy Set if “Use By” date has expired, as sterility or function may be compromised.
• Visually inspect the Thrombectomy Set prior to use to ensure that no damage has occurred during shipment. Do not use a damaged Thrombectomy Set for patient treatment.
• Do not attempt to straighten or use the Thrombectomy Set if it is bent or kinked. Attempting to do so may result in catheter rupture.
• Prime the Thrombectomy Set outside the patient; priming inside the patient may lead to embolism.
• After priming, do not operate the catheter without a guidewire in place as this will affect System performance.
• Do not exceed the wire compatibility listed in Table 1. Attempting to use a larger guidewire will damage the catheter and the guidewire.
• If resistance is felt during the advancement of the Thrombectomy Set to the lesion site, do not force or torque the catheter excessively. This may result in deformation of tip components which may degrade catheter performance.
• Do not pull the catheter against abnormal resistance. If increased resistance is felt when withdrawing the catheter, remove the catheter or guide catheter together with the sheath as a unit to prevent possible catheter damage or separation.
• Do not retract the guidewire into the catheter during operation. If retraction of the guidewire into the catheter occurs, it may be necessary to remove both the catheter and the guidewire from the patient in order to reload the catheter over the guidewire.
• Do not deliver contrast medium via hand injection with excessive force or by using a power injector. This can generate pressures greater than 50 psi which can cause leaks in the waste tubing of the Thrombectomy Set.
• Contrast agents can thicken in the catheter lumen and block proper catheter operation if left static too long. The catheter should be operated to clear the fluid within 15 minutes of injection.

• Potential adverse events which may be associated with use of the AngioJet Thrombectomy System when used as indicated include, but are not limited to:
• Allergic reaction (to drug, contrast, device or other)
• Aneurysm
• Arrhythmia
• Bleeding/hemorrhage
• Cerebrovascular accident (CVA), transient ischemic attack (TIA)
• Death
• Electric shock
• Embolism (air, plaque, thrombus, device or other)
• Hematoma
• Hemolysis
• Hypotension/hypertension
• Infection/sepsis
• Myocardial ischemia/infarction
• Need for additional intervention or surgery
• Pain
• Pancreatitis
• Renal insufficiency/failure
• Thrombus/thrombosis
• Vasospasm
• Vessel occlusion
• Vessel trauma (dissection, injury, perforation, pseudoaneurysm, rupture)

91076214 AE

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The AngioJet AVX Thrombectomy Set is intended for use with the AngioJet System in breaking apart and removing thrombus from A-V access conduits ≥ 3.0 mm in diameter.

Do not use the Thrombectomy Set in patients:

• who are contraindicated for endovascular procedures
• in whom the lesion cannot be accessed with a guidewire
• who cannot tolerate contrast media

• Refer to the AngioJet Console Operator’s Manual for other warnings, precautions, and system setup instructions.
• The Thrombectomy Set has not been evaluated for treatment of pulmonary embolism. There are reports of serious adverse events, including death, associated with cases where the Thrombectomy Set was used in treatment of pulmonary embolism.
• Operation of the catheter may cause embolism and/or vessel occlusion.
• Cardiac arrhythmias during catheter operation have been reported in a small number of patients. Cardiac rhythm should be monitored during catheter use and appropriate management, such as temporary pacing, can be employed, if needed.
• Do not use the AngioJet System in patients who have an injury in the target vessel to avoid further vessel trauma or hemorrhage.
• Do not use the Thrombectomy Set in vessels smaller than the minimum vessel diameter as listed in Table 1; such use may increase risk of vessel trauma.
• In addition to the heparin added to the saline supply bag, systemic heparinization is advisable to avoid thrombosis.
• Use of the Thrombectomy Set may result in hemolysis which should be monitored to manage possible renal, pancreatic, or other adverse events. Table 3 lists maximum recommended operating times for the procedure. Evaluate the patient’s risk tolerance for hemolysis (such as body size, thrombus burden, and renal function) prior to the procedure. Consider appropriate hydration prior to, during, and after the procedure.
• Obstructed lesions that are difficult to cross with the catheter to access thrombus may be balloon-dilated with low pressure (≤2 atm). Failure to pre-dilate difficult-to-cross lesions prior to catheter operation may result in vessel trauma.
• Monitor thrombotic debris/fluid flow exiting the Thrombectomy Set via the waste tubing during use. If blood is not visible in the waste tubing while the AngioJet System is activated in Thrombectomy Mode, the catheter may be occlusive within the vessel; verify catheter position, vessel diameter, and thrombus status. Operation under occlusive conditions may increase risk of vessel trauma.

• Use the Thrombectomy Set only with the AngioJet Console.
• Verify “Use By” date printed on the product label has not expired. Do not use the Thrombectomy Set if “Use By” date has expired, as sterility or function may be compromised.
• Visually inspect the Thrombectomy Set prior to use to ensure that no damage has occurred during shipment. Do not use a damaged Thrombectomy Set for patient treatment.
• Do not attempt to straighten or use the Thrombectomy Set if it is bent or kinked. Attempting to do so may result in catheter rupture.
• Prime the Thrombectomy Set outside the patient; priming inside the patient may lead to embolism.
• After priming, do not operate the catheter without a guidewire in place as this will affect System performance.
• Do not exceed the wire compatibility listed in Table 1. Attempting to use a larger guidewire will damage the catheter and the guidewire.
• If resistance is felt during the advancement of the Thrombectomy Set to the lesion site, do not force or torque the catheter excessively. This may result in deformation of the tip components which may degrade catheter performance.
• Do not pull the catheter against abnormal resistance. If increased resistance is felt when withdrawing the catheter, remove the catheter together with the sheath or guide catheter as a unit to prevent possible catheter damage or separation.
• Do not exchange the guidewire. Do not retract the guidewire into the catheter during operation. If retraction of the guidewire into the catheter occurs, it may be necessary to remove both the catheter and the guidewire from the patient in order to reload the catheter over the guidewire.
• Do not deliver contrast medium via hand injection with excessive force or by using a power injector. This can generate pressures greater than 50 psi which can cause leaks in the waste tubing of the Thrombectomy Set.
• Contrast agents can thicken in the catheter lumen and block proper catheter operation if left static too long. The catheter should be operated to clear the fluid within 15 minutes of injection.

Potential adverse events which may be associated with use of the AngioJet Thrombectomy System when used as indicated include, but are not limited to:

• Allergic reaction (to drug, contrast, device or other)
• Aneurysm
• Arrhythmia
• Bleeding/hemorrhage
• Cerebrovascular accident (CVA), transient ischemic attack (TIA)
• Death
• Electric shock
• Embolism (air, plaque, thrombus, device or other)
• Hematoma
• Hemolysis
• Hypotension/hypertension
• Infection/sepsis
• Myocardial ischemia/infarction
• Need for additional intervention or surgery
• Pain
• Pancreatitis
• Renal insufficiency/failure
• Thrombus/thrombosis
• Vasospasm
• Vessel occlusion
• Vessel trauma (dissection, injury, perforation, pseudoaneurysm, rupture)

92289692 D

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