The Penumbra Indigo® System Separator™ is intended for use with our Indigo System’s Continuous Aspiration Mechanical Thrombectomy (CAT) catheter to aid in the removal of clot from peripheral vessels.
The Indigo Separator is advanced and retracted through the CAT catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the catheter tip.
The Indigo System with the Separator enables a wide range of clot morphology to be removed from the body.
- SEP8 (150 cm)
- SEP6 (175 cm)
- SEP5 (175 cm)
- SEP3 (190 cm)
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Prior to use, please refer to the Instructions for Use for Indigo Aspiration System and Pump MAX for complete product indications, contraindications, warnings, precautions, potential adverse events and detailed instructions for use.
Indication For Use
Indigo® Aspiration Catheters and Separators
As part of the Indigo® Aspiration System, the Indigo Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
Indigo Aspiration Tubing
As part of the Indigo Aspiration System, the Indigo Sterile Aspiration Tubing is indicated to connect the Indigo Aspiration Catheters to the Penumbra Pump MAX™.
Not for use in the coronaries or the neurovasculature.
• The Indigo Aspiration System should only be used by physicians who have received appropriate training in interventional techniques.
• Do not advance, retract or use any component of the Indigo System against resistance without careful assessment of the cause using fluoroscopy. If the cause cannot be determined, withdraw the device or system as a unit. Unrestrained torquing or forced insertion of the catheter or separator against resistance may result in damage to the device or vessel.
• Do not use the Indigo Aspiration System with a pump other than the Penumbra Aspiration Pump.
• The device is intended for single use only. Do not resterilize or reuse. Resterilization and/or Reuse may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target vasculature location.
• Do not use kinked or damaged devices. Do not use open or damaged packages. Return all damaged devices and packaging to the manufacturer / distributor.
• Use prior to the “Use By” date.
• Use the Indigo Aspiration System in conjunction with fluoroscopic visualization.
• Maintain a constant infusion of appropriate flush solution.
• When performing aspiration ensure the Indigo Aspiration Tubing valve is open for only the minimum time needed to remove thrombus. Excessive aspiration or failure to close the Indigo Aspiration Tubing valve when aspiration is complete is not recommended.
• The Indigo Separator™ is not intended for use as a guidewire. If repositioning of the Indigo Aspiration Catheter is necessary during the revascularization procedure, such repositioning should be performed over an appropriate guidewire using standard microcatheter and guidewire techniques.
• Do not use automated high-pressure contrast injection equipment with the Indigo Aspiration Catheter because it may damage the device.
Potential Adverse Events
Possible complications include, but are not limited to, the following:
• allergic reaction and anaphylaxis from contrast media
• acute occlusion
• air embolism
• arteriovenous fistula
• device malfunction
• distal embolization
• false aneurysm formation
• hematoma or hemorrhage at access site
• inability to completely remove thrombus
• kidney damage from contrast media
• neurological deficits including stroke
• vessel spasm, thrombosis, dissection, or perforation
• intimal disruption
• myocardial infarction
• emergent surgery
• respiratory failure
• peripheral thromboembolic events
Indication For Use
The Penumbra Pump MAX™ is indicated as a vacuum source for Penumbra Aspiration Systems.
There are no contraindications.
• The canister / tubing is intended for single use only. Do not reuse. Reuse may result in the inability to aspirate.
• Do not block bottom or back air vents. Unit may overheat and shut off or fail to restart if run for extended periods without airflow.
• To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
• Do not position the pump so that it is difficult to operate the power cord disconnection device.
• Remove and service the pump if liquids or solids have been drawn into the vacuum pump.
• Do not use in the presence of flammable anesthetic mixture with air or nitrous oxide.
• Do not use in oxygen rich environment.
• To prevent fire or shock hazard, use replacement fuses of equal size and rating.
• To prevent fire or shock hazard, use a replacement power cord of equal rating.
• Do not re-infuse blood or fluid from the canister back into the patient.
• Do not use petroleum base compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. It will reduce service life of the pump. Use only water-base solvents for cleaning.
• Federal law (USA) restricts this device to sale by or on the order of a physician.
• No modification of this equipment is allowed.
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