OPTICROSS™ 18 CATHETER AND MDU5 PLUS BAG

INTENDED USE/INDICATIONS FOR USE

OptiCross 18 (30 MHz Peripheral Imaging Catheter)
This catheter is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.

MDU5 PLUS Sterile Bag
The MDU5 PLUS Sterile Bag is intended to cover the motordrive during intravascular ultrasound procedures to maintain the sterile field and prevent transfer of microorganisms, body fluids and particulate material to the patient and healthcare worker.

CONTRAINDICATIONS

OptiCross 18 (30 MHz Peripheral Imaging Catheter)
Use of this product is contraindicated in the presence of conditions which create unacceptable risk during catheterization.

MDU5 PLUS Sterile Bag
None known.

WARNINGS

OptiCross 18 (30 MHz Peripheral Imaging Catheter)

• No modification of this equipment is allowed.
  
• Air entrapped in the catheter and flushing accessories can cause potential injury or death. Always verify that the catheter and flushing accessories have been properly cleared of air prior to inserting the catheter into the vasculature.  The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. Using an altered catheter can result in poor image quality or patient complications.
  
• Do not pinch, crush, kink or sharply bend the catheter at any time. This can cause poor catheter performance, vessel injury or patient complications. An insertion angle greater than 45° is considered excessive.
  
• Do not manipulate, advance and/or withdraw the coated device through a metal cannula or needle. Manipulation, advancement and/or withdrawal through such a metal device may result in destruction and/or separation of the outer hydrophilic coating, resulting in coating material remaining in the vasculature, which may cause adverse events and require additional intervention.
• Never advance or withdraw the imaging catheter without fluoroscopic visualization because it may cause vessel injury or patient complications.
• Do not advance the catheter if resistance is encountered. The catheter should never be forcibly inserted into lumens narrower than the catheter body or forced through a tight stenosis. A catheter that is forcibly advanced may cause catheter damage resulting in vessel injury or patient complications.
• When advancing the catheter through a stented vessel, catheters that do not completely encapsulate the guidewire may engage the stent between the junction of the catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
  
• If resistance is met upon withdrawal of the catheter, verify resistance using fluoroscopy, then remove the entire system simultaneously. A catheter that is forcibly removed may cause vessel injury or patient complications.
  
• When readvancing a catheter after deployment of stent(s), at no time should a catheter be advanced across a guidewire that may be passing between one or more stent struts. A guidewire may exit between one or more stent struts when recrossing stent(s). Subsequent advancement of the catheter could cause entanglement between the catheter and the stent(s), resulting in entrapment of catheter/guidewire, catheter tip separation and/or stent dislocation. Use caution when removing the catheter from a stented vessel.
• Inadequately apposed stents, overlapping stents, and/or small stented vessels with distal angulation may lead to entrapment of the catheter with the stent upon retraction. When retracting the catheter, separation of a guidewire from an imaging catheter or bending of the guidewire may result in kinking of the guidewire, damage to the catheter distal tip, and/or vessel injury. The looped guidewire or damaged tip may catch on the stent strut resulting in entrapment.
• If multiple insertions are required, the catheter should not be disconnected from the MDU5 PLUS to avoid possible breach of catheter sterility.

MDU5 PLUS Sterile Bag
None known.

PRECAUTIONS

OptiCross 18 (30 MHz Peripheral Imaging Catheter)

• Do not attempt to connect the catheter to electronic equipment other than the designated systems because the catheter may not function properly.
  
• Never attempt to attach or detach the catheter while the motor is running. To do so may damage the connector.
  
• If difficulty is encountered when backloading the guidewire into the distal end of the catheter, inspect the guidewire exit port for damage before inserting the catheter into the vasculature. The use of a damaged guidewire exit port could increase the resistance of catheter advancement or withdrawal.
  
• Never advance the imaging catheter without guidewire support because it can cause difficulty in reaching the intended region of interest or can cause the distal catheter tip to kink.
  
• Never advance the distal tip of the imaging catheter near the very floppy end of the guidewire. This part of the guidewire will not adequately support the catheter. A catheter advanced to this position may not follow the guidewire when it is retracted and cause the guidewire to buckle into a loop which the catheter may drag along the inside of the vessel and catch on the guide catheter tip. If this occurs, it may be necessary to remove the catheter assembly, guidewire and the guide catheter together. If the catheter is advanced too near the end of the guidewire, advance the guidewire while holding the imaging catheter steady. If this fails, withdraw the catheter and guidewire together.
  
• Never advance or withdraw the imaging catheter without the imaging core assembly being positioned at the most distal position of the imaging window because it may cause the catheter to kink.
  
• During and after the procedure, inspect the catheter carefully for any damage which may have occurred during use. Multiple insertions may lead to catheter exit port dimension change/distortion which could increase the chance of the catheter catching on the stent. Care should be taken when re-inserting and/or retracting catheter to prevent exit port damage.
  
• Always turn the MDU5 PLUS “OFF” before withdrawing the imaging catheter because it could cause the motor drive to overload.
  

MDU5 PLUS Sterile Bag
None known.

ADVERSE EVENTS

OptiCross 18 (30 MHz Peripheral Imaging Catheter)
Potential adverse events which may be associated with vascular imaging include but are not limited to: 

• Allergic reaction (contrast, device or other)
  
• Arrhythmia
• Cerebral Vascular Accident (CVA)/Transient Ischemic Attack (TIA)
  
• Death
• Embolism (air, device, thrombus, tissue, plaque, or other)  
  
• Hematoma
  
• Hemorrhage
• Hypotension
• Infection/Sepsis
  
• Ischemia
• Need for additional intervention or surgery
• Radiation Injury
  
• Thrombosis/thrombus
• Vasospasm
• Vessel occlusion
• Vessel trauma (dissection, perforation, pseudoaneurysm, rupture, or injury)

MDU5 PLUS Sterile Bag
None known.