WATCHDOG™ Hemostasis Valve and Kit

Indications, Safety, and Warnings

Intended Use/Indications for Use:

The WATCHDOG Hemostasis Valve is intended to maintain hemostasis during diagnostic/interventional procedures. The WATCHDOG Hemostasis Valve is indicated for maintaining a seal around diagnostic/interventional devices with combined outer diameters of up to 8F [0.105 in (2.67 mm)] during diagnostic/interventional procedures.

Contraindications:

WATCHDOG Hemostasis Valve is not intended to be used with pressure injections > 2,758 kPa (400 psi).

Warnings:

Do not inject any fluid if air bubbles are visible within the WATCHDOG Hemostasis Valve.

Precautions:

Do not use the WATCHDOG hemostasis valve with any guidewire insertion tool < 86.4 mm (3.4 in) in length as this may result in guidewire damage. Failure to depress the plunger and/or have the distal seal fully open prior to inserting a guidewire insertion tool could cause seal damage and insertion tool damage resulting in blood and contrast injection fluid leakage and difficulty in advancing/removing the interventional device respectively and/or particulate embolization. Failure to depress the plunger and/or have the distal seal fully open prior to inserting balloon dilatation catheters/stent delivery systems could cause damage to the devices or stent dislodgement.

Adverse Events:

• Air Embolism
• Hemorrhage
• Infection

Caution:

Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.