The JETi™ Thrombectomy System is designed to treat both peripheral arterial thrombosis and peripheral venous thrombosis.1
The JETi™ thrombectomy device leverages cutting-edge technology to treat both peripheral arterial and venous thrombus with a novel hydrodynamic system.1 Utilizing a uniquely positioned high-pressure saline jet, JETi is able to fragment and lubricate clot safely within the catheter lumen to help avoid clogging1 and potential patient exposure to hemolytic compounds.2,4 With HyperPulse™ Fluid Delivery, JETi can also sub selectively infuse/deliver diagnostics or therapeutics intra-procedurally.1
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IMPORTANT SAFETY INFORMATION
JETi™ All-In-One Peripheral Thrombectomy System
Indications
The JETi™ AIO Peripheral Thrombectomy System is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.
Contraindications
The JETi™ AIO Peripheral Thrombectomy System is contraindicated for use in:
Vessels smaller than 4 mm (0.16”)
Coronary, pulmonary, and neurovasculature
Warnings
The JETi™ Peripheral Catheter, JETi™ AIO Suction Tubing, and JETi™ Pump Set contents are supplied sterile using EO. Do not use if the expiration date has passed or the sterile barrier is damaged.
The JETi™ Peripheral Catheter, JETi™ AIO Suction Tubing, JETi™ AIO Non-Sterile Kit, and JETi™ Pump Set contents are for single patient use only. Dispose after use. Do not reuse, reprocess, modify, or resterilize. Reuse, reprocessing, modification, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, may result in patient injury, illness or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient.
The JETi™ AIO Peripheral Thrombectomy System is not approved for use with defibrillation. In the event shock must be delivered to the patient, remove the catheter and clear all connected system components from the patient before delivering shock.
Do not use a catheter that has been kinked or damaged.
Do not use a pump set if it does not prime.
Only use the JETi™ Peripheral Catheter and JETi™ AIO Suction Tubing with the JETi™ AIO Peripheral SDU.
Do not mix contrast media in the saline bag.
When the catheter is exposed to the arterial system, it should be manipulated while under high-quality fluoroscopic observation.
In the event that the catheter becomes blocked or clogged with thrombus, remove and replace the device with a new device.
Do not use if package is opened or damaged.
To avoid risk of electric shock, the SDU must only be connected to mains power with a protective earth.
The power socket-outlet must be located near the device and must be easily accessible.
Do not modify or alter the device.
Do not step or stand on the base of the device.
Do not push or lean against the IV pole.
Precautions
Physicians must read and understand the Instructions for Use (IFU) prior to using the device. The device must be used by physicians skilled in percutaneous, intravascular techniques in a fully equipped catheterization laboratory.
Potential Adverse Effects
Potential adverse events include, but are not limited to:
Acute closure
Aneurysm or pseudo aneurysm
Allergic reaction to contrast
Arrhythmia
Death
Embolism (air or device)
Embolization (thrombotic)
Emergency surgery
Access site pain, hemorrhage, or hematoma
Infection (systemic/sepsis)
Local infection (puncture site)
Minimal blood loss
Vessel dissection, perforation, or other injury
Vessel spasm
Thrombosis
JETi™ is a trademark of Walk Vascular. Walk Vascular is a subsidiary of the Abbott Group of Companies. Manufactured by Walk Vascular LLC 17171 Daimler Street, Irvine CA, 92614 USA
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Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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JETi™ All-In-One Peripheral Thrombectomy System
