INDICATIONS, SAFETY, AND WARNINGS Crescent™* Jugular Dual Lumen Catheter and Opus™* Vascular Access Kit

Crescent jugular dual lumen catheter

indications for use

The Crescent™* jugular dual lumen catheter is a single-use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in patients with acute respiratory failure requiring veno-venous extracorporeal membrane oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent.

CONTRAINDICATION

This device is not designed, sold, or intended for use except as indicated.

Warnings and Precautions

Warning: Do not use without adequate systemic anticoagulation.

Warning: Use of the Crescent jugular dual lumen catheter beyond the duration established by the available in vitro and in vivo testing has not been demonstrated. Please refer to Section 14 for a summary of bench and animal studies performed, as well as Section 9 of the IFU for the possible clinical observations that may necessitate or predict the need for device replacement/change-out throughout the duration of use for this device.

Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgery procedures. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

 

Opus Vascular Access Kit    

Indications

The Opus™* vascular access kit is intended for single use by a trained physician to assist in vessel cannulation.

Contraindication

This device is not designed, sold, or intended for use except as indicated.

Warnings and Precautions

Warning: Only physicians trained and experienced with vessel cannulation should use this device.

Caution: The steps contained in the IFU discuss the Seldinger Technique of percutaneous entry and are for information purposes only. Each physician should evaluate their appropriateness according to individual patient condition and his or her medical training and experience.

Warning: Vascular perforation is an inherent risk of any catheter placement and that incorrect insertion or repositioning can cause damage to the vessels and anatomical structures.

Warning: Patient and procedure selection are the responsibility of the physician.

Warning: Carefully read all instructions prior to use. Observe all warnings and cautions. Failure to do so may result in complications.

Warning: Do not resterilize. Do not reprocess. Reprocessing may compromise the sterility, biocompatibility, and functional integrity of the device. Reuse of this device may lead to patient cross-contamination and/or device failure.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

*

Third party brands are trademarks of their respective owners.

Crescent™* jugular dual lumen catheter and Opus™* vascular access kit are manufactured by MC3, Inc. and exclusively distributed by Medtronic.