Indications, safety and warnings for CATAPULT™ Guide Sheath System

The Catapult Guide Sheath system is not designed, sold or intended for any use other than indicated. 

It is the responsibility of the physician to determine whether any physical impairment of the patient would contraindicate the use of this device. Do not attempt introducer sheath insertion or use if the following conditions apply: 

• Anatomical irregularities in the patients extremities that could interfere with proper placement of the catheter.

• An adjacent vascular access device that could compromise catheter care and cleanliness. 

• Prior trauma to vessels that could interfere with insertion of the catheter.

• Infection or lesion near the insertion site.

• Radial access is contraindicated if there is an abnormal Allen’s Test, radial pulse, or insufficient dual arterial supply.

• Read the instructions prior to use. 
• This device should only be used by or under the direction of physicians thoroughly trained in the technique of catheter delivery systems. 
• This device is intended for single use only. Do not reuse, resterilize or autoclave. Reuse of single use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. Cleaning, disinfection and sterilization may compromise essential material and design characteristics leading to device failure. CMI GmbH will not be responsible for any direct, incidental or consequential damages resulting from resterilization or reuse. 
• Do not alter this device. Alterations may impair function. 
• Do not attempt to advance or withdraw the introducer sheath, guide wire, catheter, or other interventional device if resistance is felt. Use fluoroscopy to determine the cause. If the cause cannot be determined and corrected, discontinue the procedure and withdraw the introducer sheath. Continued advancement or retraction against resistance may result in serious injury, and / or breakage of the guide wire, introducer sheath, catheter or interventional medical device. 
• Do not use the device if the package or contents appear damaged in any way. 
• Protection tube from sheath and dilator must be removed prior to use. 
• Do not use the device with a power injector. 
• Verify compatibility of the introducer sheath, device, catheter and accessories prior to use. 
• Do not attempt to use a guide wire with a maximum diameter greater than specified on package label. Device damage or breakage may occur. 
• Do not attempt to insert a catheter or other interventional device with a diameter larger than the introducer sheath size indicated. Device damage or breakage may occur. 
• Observe sterile technique at all times when handling and inserting or removing the catheter. 
• Adequate heparinization must be maintained during the procedure. 
• Device contains metal parts: do not expose to MRI. 
• The medical techniques and procedures described in these instructions are presented as an example only, and do not represent ALL medically acceptable protocols. They are not intended as a substitute for the physicians experience and judgment in treating any specific patient. 
• Do not leave the introducer sheath in place for extended periods of time without a catheter or obturator to support the cannula wall. 

Radial access:

• Prior to beginning radial artery access, an assessment such as the Allen’s test should be performed to access the presence/adequacy of dual arterial circulation to the hand. 

• Examine packaging and device before use. Do not use if either the packaging or device is damaged or if sterile barrier has been compromised. 
• The device is supplied sterile. The package will serve as an effective barrier until the “use by” (expiration) date printed on the box. 
• Do not expose to organic solvents. 
• Store in a cool, dry place, away from sunlight. 
• Before use, make sure the sheath (Fr.) and dilator size are appropriate for the access vessel and the system to be used. 
• Individual patient anatomy and physician technique may require procedural variations. 
• Do not attempt introducer sheath advancement or withdrawal without guide wire and dilator secured in place. Severe vascular damage and / or injury may occur. 
• Insertion into and removal from artery may cause excessive bleeding and / or other complications. 

Potential complications include, but are not limited to:

• Air embolism 
• Bleeding 
• Hematoma 
• Infection / Sepsis 
• Intimal tear 
• Thromboembolism 
• Thrombophlebitis 
• Thrombosis 
• Vessel spasm 
• Perforation or laceration of the vessel wall 
• Risks normally associated with percutaneous diagnostic and / or interventional procedures

Some of the complications listed above could result in death or serious injury to the patient.