INDICATIONS, SAFETY, AND WARNINGS

Crescent™*
Jugular Dual Lumen Catheter

Indications for use

The 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.

Contraindications

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 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.

 

Crescent™* Jugular Dual Lumen Catheter is manufactured by MC3, Inc. and exclusively distributed by Medtronic.

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