JETi™ Hydrodynamic Thrombectomy System

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.
• During operation, maneuvering the cart should be kept to a minimum. Wheel locks should be engaged while the cart is stationary and in use. Do not step or stand on the base of the device while in use.
• Ensure wheel locks are disengaged before attempting to maneuver the cart. Ensure power cable is coiled around the cable holder before moving. Ensure all other accessories, cables, and devices are disconnected from the SDU and stored or discarded before maneuvering. Do not grip or apply lateral force to the IV pole. Grip or apply lateral force to the cart handle. Ensure the cart is stabilized by two persons if maneuvering over an elevated threshold. Do not step or stand on the base of the device while maneuvering.
• Electrical Shock Hazard. To avoid electrical shock, use only the power cords supplied with the system and connect only to properly grounded wall outlets.
  Make sure the power cord is connected to the system and is plugged into a grounded electrical outlet.
• Never use a converter adapter to plug the three-pronged AC plug into a two-pronged ungrounded wall outlet. Doing so may result in electric shock to the patient or operator and damage to equipment.
• To maintain compliance with regulatory standards, all components supplied with the system or specified as part of the system are to be powered by power supplies and power cords provided with the system. No unauthorized substitutions are permitted.
• When using this product, wear disposable gloves, protective gowns, face masks or eye coverings, as appropriate when handling HIV-1 (AIDS Virus), HBV, or HCV-infected blood or body fluids. After use, the JETi Catheter, JETi Pump Set, JETi Suction Tubing, and JETi Non-sterile Canister Set may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
• Ensure the vacuum sensor cord end does not get wet, as it may damage sensor and / or SDU.

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

Potential Adverse Effects

Potential adverse events include, but are not limited to:

• Access site pain, hemorrhage, or hematoma
• Acute closure
• Amputation
• Aneurysm or pseudoaneurysm
• Allergic reaction to contrast
• Arrhythmia
• Compartment syndrome
• Death
• Embolism (air or device)
• Embolization (thrombotic)
• Emergency surgery
• Infection (systemic/sepsis)
• Local infection (puncture site)
• Minimal blood loss
• Thrombosis
• Vessel dissection, perforation, or other injury
• Vessel spasm