Reuse Warning; Device Description; Contents; Operating Principle And Device Detail - Boston Scientific Hurricane Rx Gebrauchsanweisung

Hurricane
Balloon Dilatation Catheter
Caution: Federal Law (USA) restricts this device to sale by or on the
order of a physician.

REUSE WARNING

For single use only. Do not reuse, reprocess or sterilize. Reuse,
reprocessing or sterilization may compromise the structural
integrity of the device and/or lead to device failure which, in turn,
may result in patient injury, illness or death. Reuse, reprocessing or
sterilization may also create a risk of contamination of the device
and/or cause patient infection or cross-infection, including, but not
limited to, the transmission of infectious disease(s) from one patient
to another. Contamination of the device may lead to injury, illness or
death of the patient.

DEVICE DESCRIPTION

Contents

Balloon dilatation catheter
(1) Stopcock
(1) FloSwitch
(1) Preloaded stylet

Operating Principle and Device Detail

The Hurricane RX Biliary Balloon Dilatation Catheter is a double
lumen catheter with a balloon mounted at the distal tip. Dilatation
balloon catheters are used to exert radial force to dilate narrow duct
segments, as well as the Sphincter of Oddi.

Balloon Construction

Balloons are constructed with specially treated polymers and
processes, which provide maximum strength. Each balloon inflates
to its stated diameter and length at a specific pressure. Maximum
pressure is dependent on the balloon size and is identified on the label.
Warning: 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.

Catheter Construction

The catheter is multi-lumen. The guidewire lumen begins at the
distal tip of the catheter, travels under the black sleeve where it
exits at the proximal end of the black sleeve, which is 25 cm from
the catheter tip. This lumen is used to pass the catheter over a
0.035 in (0.89 mm) guidewire to provide for the rapid exchange
feature. The lumen marked "Balloon" is the balloon inflation
lumen. The catheter shaft tapers beneath the balloon segment to
achieve the lowest possible deflated profile. The lumen marked
"Injection", at the proximal end of the catheter, can be used for
contrast medium injection for fluoroscopic visualization of the
bile duct. There is a FloSwitch Adapter connected to the hub of the
"Injection" lumen. The FloSwitch Adapter is to remain closed until
distal dye contrast injections are required.
Two radiopaque markers are placed under the balloon segment
of the catheter to provide visual reference points for balloon
positioning within the stricture or duct. A stainless steel stiffening
stylet is inserted in the proximal portion of the catheter shaft to
augment catheter pushability through the endoscope and should
be left in place. This stylet ends under the black tunnel.
37 MB Drawing 50573137
B I L I A R Y
ONLY
RX
™
3
Black (K) ∆E ≤5.0