MAC-1200

Indications, Safety, and WarningsCautionFederal (USA) law restricts this device to sale by or on the order of a physician.Indications for useThe Riptide™ Aspiration System is intended for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.ContraindicationsThere are no known contraindications.Precautions

The catheter and the aspiration tubing are supplied sterile and are intended for single use only. Do not resterilize or re-use. Resterilization and/or re-use may result in ineffective catheter coating lubrication, which may result in high friction and the inability to access the target neuro vasculature location.

Use the catheter, aspiration tubing, and Riptide™ Collection Canister with Intermediate Tubing prior to the “Use-by date”.

The Riptide™ Aspiration Pump and Riptide™ Collection Canister with Intermediate Tubing are supplied non-sterile and are intended for use outside of the sterile field only.

The Riptide™ Collection Canister with Intermediate Tubing is intended for single use only. Dispose in accordance with standard biologic waste disposal procedures.

Do not use kinked or damaged devices. Do not use open or damaged packages.

Inspect the catheter before use to verify that its size and condition are suitable for the specific procedure.

Use the catheter under fluoroscopic guidance to confirm placement of the catheter proximal to the thrombus prior to applying aspiration.

Maintain a constant infusion of appropriate flush solution.

When performing aspiration, ensure that the aspiration tubing flow switch is in the open position for only the minimum time needed to remove thrombus.

The recommended continuous duration of aspiration is a maximum of 90 seconds.

If repositioning of the catheter is necessary during the revascularization procedure, such reposition should be performed over an appropriate neurovascular guidewire and/or microcatheter using standard techniques.

Do not use automated high-pressure contrast injection equipment with the catheter because it may damage the device.

Medical management and post stroke care should follow AHA/ASA guidelines and institutional protocols.

As in all surgical interventions, monitoring of intra-procedural blood loss is recommended so that appropriate management may be instituted.

Possible malfunctions of the Riptide™ Aspiration System include, but are not limited to issues associated with vacuum for the aspiration tubing, Riptide™ Aspiration Pump, and Riptide™ Collection Canister with Intermediate Tubing that may lead to decreased therapeutic response during mechanical thrombectomy.

Operators should take all necessary precautions to limit X-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.

Potential adverse events

acute occlusion

allergic reaction and anaphylaxis from contrast media

arrhythmia

complication at puncture site

complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)

death

decreased therapeutic response

embolism

fistula

foreign body in patient

hypertension/hypotension

infection

inflammation

intracranial hemorrhage

ischemia

nerve damage

neurological deficits including stroke

organ failure/shock

pain

stenosis

vessel spasm, thrombosis, dissection, or perforation

Warnings

The Riptide™ Aspiration System should only be used by physicians who have received appropriate training in interventional neuro-endovascular techniques for treatment of acute ischemic stroke. The Riptide™ Aspiration System is designed for setup by clinical support staff under the supervision of a trained physician.

Do not advance, retrieve, or use any component of the Riptide™ Aspiration 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 against resistance may result in damage to the device or vessel.

For vessel safety, do not perform more than three attempts at aspiration in the same vessel using the Riptide™ Aspiration System.

Do not use devices in conjunction with or in place of those devices specified above when using the Riptide™ Aspiration System.

Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device.US-NNP-2400108 (v1.0)

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