Materials; User Information; Intended Use/Indications For Use; Clinical Benefit Statement - Boston Scientific Hurricane Rx Gebrauchsanweisung

Materials

Contains cobalt: CAS No. 7440-48-4; EN No. 231-158-0.
Defined as a 1B carcinogen and reproductive toxicant
according to the European Commission in a concentration
above 0.1% weight by weight.
Note: This device is made with stainless steel which
contains cobalt. Current scientific evidence supports that
stainless steels used in medical devices, do not cause an
increased risk of cancer or adverse reproductive effects.

User Information

A thorough understanding of the technical principles, clinical
applications and risks associated with balloon dilatation of the
biliary tract is necessary before using this product.

INTENDED USE/INDICATIONS FOR USE

The Hurricane RX Biliary Balloon Dilatation Catheter is recommended
for endoscopic dilatation of strictures of the biliary tree and the
Sphincter of Oddi.
The Hurricane RX Biliary Balloon Dilatation Catheter may be used
for injection of contrast medium for fluoroscopic visualization of the
bile ducts.

Clinical Benefit Statement

The clinical benefit of the Hurricane RX Biliary Balloon Dilatation
Catheter is to facilitate endoscopic dilatation of strictures of the
biliary tree and sphincter of Oddi and enables distal contrast
injections for fluoroscopic visualization of bile ducts.

CONTRAINDICATIONS

None known.

WARNINGS

• To prevent balloon burst, do not exceed the Maximum Pressure
printed on the label as this can lead to balloon burst and/or
patient injuries, such as perforation, hemorrhage and/or
tissue damage.
• To ensure minimum balloon profile, do not pre-inflate, pretest
balloon, or attempt to refold balloon into protective sleeve as
this could lead to patient injury.

PRECAUTIONS

Any use of this product for procedures other than those indicated in
these instructions is not recommended.
• Monitor pressure using an inflation device and pressure gauge.
As dilatation takes place, the pressure reading may fluctuate.
Adjust the balloon inflation pressure, as necessary to maintain
desired pressure.
• If the balloon does rupture or a significant loss of pressure
within the balloon occurs, deflate the balloon and carefully
remove the balloon and endoscope together as a unit. Do not
attempt to withdraw a ruptured balloon through
the endoscope.

ADVERSE EVENTS

The adverse events that may result from a balloon dilatation
procedure include but may not be limited to:
• Allergic reaction
• Hemorrhage
• Infection/sepsis
• Inflammation
• Pain and tenderness
• Perforation
• Tissue damage
Black (K) ∆E ≤5.0
4
MB Drawing 50573137