iLab™ Ultrasound Imaging System with the Ultra ICE™ Catheter

Prescriptive Information

Intended Use and Indication(s) for iLab™ System Use:
The iLab Ultrasound Imaging System is intended for ultrasound examinations of intravascular pathology. Intravascular ultrasound is indicated in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy. Refer to the Catheter DFU provided with all BSC Ultrasound Imaging Catheters to determine compatibility with the iLab System. The Imaging Catheters generate ultrasound images and are intended for patient examination of vascular and cardiac anatomies. BSC manufactures a wide variety of imaging catheters for different applications. The recommended use of each of these catheters may vary depending on the size and type of catheter.
 
Contraindications
The Ultra ICE Catheter is contraindicated in the presence of conditions which create unacceptable risk during catheterization.
This device is not to be used in the coronary arteries.
    
Warnings
Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if barrier is damaged. If damage is found, call your Boston Scientific representative.
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, 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.

After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Care must be taken to ensure that any equipment used in connection with the BSC catheters, be type CF, be defibrillation proof, meet IEC 60601-1 and IEC 60601-1-2 electrical safety requirements, and comply with all local regulatory requirements for the specified intended use.

• Before using, inspect for physical damage including electrical insulation on the cables and the catheter shaft. Replace damaged equipment.

• 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.

• If resistance is met upon withdrawal of the catheter, verify resistance using fluoroscopy, then remove the entire system simultaneously.
 
Potential Adverse Effects
1. The risks and discomforts involved in imaging cardiac structures include those associated with similar types of diagnostic procedures in the heart. However, any of these risks or discomforts may occur with greater frequency or severity than previously reported. Additionally, these complications may necessitate additional medical treatment including surgical intervention.
o Myocardial infarction
o Abnormal heart rhythms
o Thrombosis
o Hematoma
o Cardiac wall injury including perforation
o Vascular wall injury including perforation
o Infection/discomfort
o Damage to cardiac valvular structures
o Hypotension/Hypertension
o Endocarditis
o Stroke/embolism
o Death

2. As with all procedures that utilize the Seldinger Technique for introducing a catheter into an artery, the following complications have been reported:

o Infection and pain in the region of the insertion site
o Hemorrhage
o Arteriovenous Fistula
 
Cautions
Federal (USA) law and governing law outside the USA restricts these devices to sale by or on the order of a physician.

PRECAUTIONS:
• This device should be used by physicians thoroughly trained in the techniques of invasive cardiology and in the specific approach to be used.

• After the procedure, inspect the catheter carefully for any damage which may have occurred during use.

• The catheter has no user serviceable parts. Do not attempt to repair or to alter any component of the catheter assembly as provided. Do not attempt to connect the catheter to electronic equipment other than the designated systems.

• Never attempt to attach or detach the catheter while the motor is running. To do so may damage the connector.

• Throughout the procedure anticoagulant therapy is recommended for patients undergoing left-sided and transseptal cardiac procedures and should be considered for selected patients undergoing right-sided procedures.

• Avoid any sharp bends, pinching or crushing of the catheter.

• Do not kink or sharply bend the catheter at any time. This can cause drive cable failure. An insertion angle greater than 45° is considered excessive.

• Turn the MDU “OFF” before withdrawing the imaging catheter, or when advancing the catheter in the body.