COOK Medical Advance Gebrauchsanweisung Seite 4

• Use the device prior to the "Do Not Use After" date specified on the package.
• The device is not intended for the delivery of stents.
• During device withdrawal, take care to keep the shaft as straight as possible. Withdrawing the device at
an excessive angle or curvature may damage the shaft.
• Do not attempt dilation if the wire guide and balloon cannot cross the lesion or stricture.
• Do not attempt usage of this product in the presence or suspected presence of unfavorable patient
anatomy.
POTENTIAL ADVERSE EVENTS
The following complications are possible with the use of balloon catheter devices:
• Pain
• Infection
• Bleeding
• Tissue dissection, perforation, rupture or injury
• Duct occlusion
• Tissue avulsion
• Damage to the facial or lingual nerve
INSTRUCTIONS FOR USE
The Advance Salivary Balloon Catheter requires imaging in order to ensure proper placement and inflation of the
balloon catheter. The choice of imaging depends on physician preference. Table 1 shows the recommended imaging
modalities and compatible ancillary devices.
Table 1: Recommended Imaging Modality and Compatible Ancillary Devices
Imaging Modality
Sialendoscopic Visualization
Sialendoscopic Visualization with
Ultrasound Imaging
1.3 mm OD sialendoscope maximum
+
Alternatively, the balloon catheter and wire can be used without an introducer sheath.
*
Balloon Catheter Preparation
1. Choose a balloon catheter diameter appropriate for treatment of the salivary duct. (See Table 2.)
Reference Balloon Diameter
1.5 mm
2.0 mm
2.5 mm
3.0 mm
Treatment Site
Submandibular
+
Submandibular
Table 2: Recommended Duct Sizing
Recommended Minimum Duct
Parotid
Diameter
1.5 mm
2.0 mm
2.5 mm
3.0 mm
4
Introducer Sheath
6 Fr
6 Fr*
N/A
Recommended Minimum Duct
Length
2 cm