Jetstream Atherectomy System

INTENDED USE/INDICATIONS FOR USE

Catheter INTENDED USE/INDICATIONS FOR USE

The JETSTREAM System is intended for use in atherectomy of the peripheral vasculature and to break apart and remove thrombus from upper and lower extremity peripheral arteries. It is not intended for use in coronary, carotid, iliac or renal vasculature.

Console INTENDED USE/INDICATIONS FOR USE

The JETSTREAM™ Console is designed for use only with the JETSTREAM Catheter and Control Pod. See the current revision of the applicable Catheter and Control Pod Directions for Use for further information.

CONTRAINDICATIONS

None known. 

WARNINGS/PRECAUTIONS

Catheter WARNINGS

• Use room temperature infusate only. Use of heated infusate may lead to wrinkling, ballooning and/or bursting of the outer catheter sheath, which could lead to injury to the patient
  
• Operating the Catheter over a kinked guidewire may cause vessel damage or guidewire fracture.
• During treatment, do not allow the Catheter tip within 10.0 cm of spring tip portion of the guidewire. Interaction between the Catheter Tip and this portion of the guidewire may cause damage to or detachment of the guidewire tip or complicate guidewire management.
• The guidewire must be in place prior to operating the Catheter in the patient. Absence of the guidewire may lead to inability to steer the Catheter and cause potential vessel damage.
• If the guidewire is accidentally retracted into the device during placement or treatment, stop use, and remove the Catheter and the guidewire from the patient. Verify that the guidewire is not damaged before re-inserting the guidewire. If damage is noticed, replace the guidewire.
• Check the infusate bag frequently and replace when needed. Do not run the JETSTREAM System without infusate as this may cause device failure.
• Hold the guidewire firmly during Catheter retraction process. Failure to do so may result in guidewire rotation within the vessel, which could cause patient injury.
• Do not manipulate the Catheter against resistance unless the cause for that resistance has been determined.
• Prior to use of the JETSTREAM System, confirm the minimum vessel diameter proximal to the lesion per the following table:

Catheter PRECAUTIONS

• Do not bend or kink the Catheter during setup or during the procedure. This may damage the device and lead to device failure.
• Do not inject contrast while the device is activated.
• Use only listed compatible guidewires and introducers with the JETSTREAM System. The use of any supplies not listed as compatible may damage or compromise the performance of the JETSTREAM System.

Console WARNINGS

• To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
  
• Use of accessories, transducers and cables other than those specified or provided by Boston Scientific could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the JETSTREAM Console, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
  
• Use of the JETSTREAM Console adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, the JETSTREAM Console and the other equipment should be observed to verify that they are operating normally.
  
• Do not attempt to bypass any of the JETSTREAM Console safety features.Store the PVCN100 Console using appropriate care to prevent accidental damage.
  
• User modification of the JETSTREAM Console is not allowed.
  
• The JETSTREAM Console is to be mounted to an IV Stand during procedures. When transporting, the Console is intended to be disconnected from the IV Stand to avoid instability and overbalancing.
  

Console PRECAUTIONS

• Observe normal safety practices associated with electrical/electronic medical equipment.
• The JETSTREAM Console requires special precautions regarding electromagnetic emissions and immunity and needs to be installed and put into service according to the information included in the Electronic and Electromagnetic Guidance Section.
• Grounding reliability can only be achieved when the power cord is connected to a “Hospital Only” or “Hospital Grade” receptacle.
• The System should only be used by physicians trained in percutaneous peripheral interventional procedures.
• Ensure the JETSTREAM Console display is visible during the entire procedure.
• Do not open either pump door during operation of the System. Doing so could result in loss of aspiration and/or infusion and will halt device activation.
• Do not place objects on the JETSTREAM Console.
• Do not immerse the JETSTREAM Console in liquids.
• Avoid excessive coiling or bending of the power cables during storage.
• Store the JETSTREAM Console using appropriate care to prevent accidental damage.
• Visually inspect the JETSTREAM Console prior to use to ensure that no damage has occurred. Do not use a damaged JETSTREAM Console for patient treatment, as patient injury may occur.
• The JETSTREAM Console is designed to be mounted on an IV Stand that meets the minimum requirements of a base with 5 wheels and an IV pole diameter of 19 mm to 32 mm. IV Stands that do not meet the minimum requirements may not provide adequate stability.
• If stability of the system is compromised, lower the Console height.

ADVERSE EVENTS

Potential adverse events associated with use of this device and other interventional catheters include, but are not limited to the following (alphabetical order):

• Abrupt or sub-acute closure
• Amputation
• Bleeding complications, access site
• Bleeding complications, non-access site
• Death
• Dissection
• Distal emboli
• Hypotension
• Infection or fever
• Minor burn
• Perforation
• Restenosis of the treated segment
• Vascular complications which may require surgical repair
• Thrombus                                                                                                                                                                                           
• Vasospasm