BD Liverty™ TIPS Access Set 

Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator’s Instruction.

BD Liverty™ TIPS Access Set

Indications for Use: The BD Liverty™ TIPS Access Set is indicated for percutaneous transjugular liver access during diagnostic and interventional procedures.

Contraindications: None known.

Select Warnings: The needle and the 5F catheter must be assembled as one unit prior to insertion into the steerable cannula and liver penetration. Insertion of the needle without the 5F catheter may result in kinking of the needle.  Use caution if using a guidewire with the puncture needle. Do not insert a guidewire with a diameter >0.018 inch through the needle. Avoid manipulating or withdrawing a guidewire through the puncture needle. The sharp edge of the puncture needle may scrape or shear material from the guidewire or the guidewire can get stuck on the needle tip. If the puncture needle is being used with a guidewire and the guidewire needs to be withdrawn, remove the guidewire and puncture needle as a unit to reduce potential damage to the wire. Refer to the Instructions for Use of the guidewire when used in conjunction with the Liverty™ TIPS Access Set.  Do not attempt to manually shape the cannula. Physical manipulation may compromise the steering mechanism of the cannula.

Select Precautions: Do not turn the orange knob on the steerable cannula when significant resistance is encountered.  During insertion of the steerable cannula through the introducer sheath, the angle of the cannula tip should not exceed 40 degrees.  Do not manipulate the angle of the steerable cannula with the sharp needle tip protruding beyond the leading end of the steerable cannula  Do not remove the puncture depth adapter unless a greater puncture depth is desired.  After the first change of the tip angle, the steerable cannula may not be 100% reset to straight and a subtle curvature may remain.

Potential Complications may include but are not limited to: Access site hematoma; Allergic reaction to contrast; Cardiac arrythmia; Embolism; Hemoperitoneum; Infectious complications such as fever, sepsis, or septic shock; Non-target organ injury (e.g.; of bile ducts, gallbladder, kidney, colon) Vessel injury (e.g.; dissection, perforation, aneurysm, pseudoaneurysm, rupture, laceration, tear, hemobilia, hemorrhage or hemorrhagic shock); Death