EchoTip® Ultra Celiac Plexus Neurolysis Needle Clinical Procedure: Case 2 - Dr. Mishra скачать в хорошем качестве

EchoTip® Ultra Celiac Plexus Neurolysis Needle Clinical Procedure: Case 2 - Dr. Mishra

Girish Mishra, M.D., M.S., Associate Professor of Internal Medicine, Director of Endoscopic Ultrasound Services, Section of Gastroenterology; Wake Forest University Baptist Medical Center, demonstrates the EchoTip® Ultra Celiac Plexus Neurolysis Needle INSTRUCTIONS FOR USE (IFU): https://ifu.cookmedical.com/data/IFU_... MORE INFO: https://www.cookmedical.com/products/... INTENDED USE This device is used to deliver neurolysing agents to the celiac plexus under guidance by endoscopic ultrasound. DEVICE DESCRIPTION The device consists of a handle with adjustable components to allow the user to adjust the extension of the needle and sheath. The device has a 6 Fr outer sheath for protection of the needle and the scope, and it is attached to the accessory channel of an ultrasound endoscope. The device has a maximum needle extension length of 8 cm and sheath adjustment length of 5 cm. The device has a cone shaped needle tip design with side holes to administer a uniform radial spray of neurolysing agent. The device is available in one needle size: 20 ga. CONTRAINDICATIONS Contraindications include those specific to the primary endoscopic procedure to be performed in gaining access to the desired injection site. Contraindications to celiac plexus neurolysis include, but are not limited to: coagulopathy • use of anticoagulants • aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs). POTENTIAL ADVERSE EVENTS Potential adverse events associated with gastrointestinal endoscopy and celiac plexus neurolysis include, but are not limited to: airway obstruction • allergic reaction to medication • allergic reaction to nickel • aspiration • cardiac arrhythmia or arrest • discomfort • fever • gastroparesis • hemorrhage • hypotension • infection • inflammation • lower extremity weakness • nausea • paraplegia • paresthesias • perforation • renal puncture • respiratory depression or arrest • sepsis • transient diarrhea • transient increasing pain • vomiting. WARNINGS Not for use in the heart or vascular system. The tip of the needle and stylet are sharp and could cause injury to the patient or user if not used with caution. This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease. If the package is opened or damaged when received, do not use. Visually inspect with particular attention to kinks, bends and breaks. If an abnormality is detected that would prohibit proper working condition, do not use. Please notify Cook Medical for return authorization. PRECAUTIONS Refer to package label for minimum channel size required for this device. The needle must be retracted into the sheath and the thumbscrew on the safety ring must be locked at the 0 cm mark to hold the needle in place prior to introduction, advancement or withdrawal of the device. Failure to retract the needle may result in damage to the endoscope. Ensure the stylet is fully inserted when advancing the needle into the target site. A thorough understanding of the technical principles, clinical applications and risks associated with endoscopic ultrasound and celiac plexus neurolysis is necessary before using this device. The use of prophylactic antibiotics is recommended for endoscopic ultrasoundguided celiac plexus neurolysis. The use of general anesthesia may be needed in some cases. Do not use this device for any purpose other than stated intended use. Use of this device is restricted to a trained healthcare professional (Rx only).