Indications for Use
The JETi™ Hydrodynamic 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™ Hydrodynamic Thrombectomy System is contraindicated for use in:
- Vessels smaller than 4 mm (0.16”)
- Coronary, pulmonary, and neurovasculature
Warnings
- The catheter, suction tubing, and pump set contents are supplied sterile using ethylene oxide (EO). Do not use if the expiration date has passed or the sterile barrier is damaged.
- The catheter, suction tubing, non-sterile canister set, and 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™ Hydrodynamic 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™ Catheter, JETI™ Pump Set, JETi™ Suction Tubing, and JETi™ Non-Sterible Canister Set with the JETi AIO Saline Drive Unit or the JETi™ Saline Drive Unit.
- 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.
- Flow aspiration could be reduced by lower atmospheric pressure at higher altitude.
- When delivering fluid through the catheter aspiration lumen, do not exceed the maximum recommended flow rate, per Table 1 below
Table 1. Catheter Fluid Delivery Flow Rate
| Fluid | Maximum Recommended Fluid Delivery Flow Rate |
|---|
| Saline | 4.0 mL/s |
| 60% Ionic Contrast Media | 1.8 mL/s |
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
