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:

The law restricts these devices to sale by or on the order of a physician.
Indications, contraindications, warnings and instructions for use can be found
in the product labelling supplied with each device. Products shown for
INFORMATION purposes only and may not be approved or for sale in certain
countries. This material not intended for use in France.

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