Boston Scientific Stingray LP Instrucciones De Uso página 3

Stingray
™
Catheter
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
REUSE WARNING STATEMENT
For single patient use only. There has been no testing to validate this device beyond
use in a single patient. Do not reuse, reprocess or resterilize. Reuse, reprocessing or
resterilization 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 resterilization 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
The Stingray LP Catheter facilitates the placement, support and steering of a guidewire
into discrete regions of the coronary vasculature through the central guidewire lumen
or through one of two side-ports. These side-ports are on opposite sides of the balloon
and are identified by radiopaque markers. The side-ports communicate with the central
guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by
allowing the guidewire to exit the Stingray LP Catheter. The Stingray LP Catheter contains
a small balloon used for fluoroscopic orientation on the distal tip of a flexible shaft. The
distal end of the catheter is hydrophilic coated. The Stingray LP Catheter is compatible
with 6F guide catheters with minimum inner diameter of 0.070 in (1.7 mm) and may be
used with ≤0.014 in (0.36 mm) guidewires. All components of the Stingray LP Catheter are
provided sterile and non-pyrogenic. For dimensional information refer to label.
Contents
Quantity Material
1 Stingray LP Catheter
Operating Principle
To achieve the intended use of Stingray LP, the catheter has an open lumen for guide
wires. A flat balloon is located at the distal end and a luer-lock hub interface is located
at the proximal end. The balloon is inflated with inflation media to orient the balloon
side-ports within the sub-intimal space of the vessel to allow the Stingray Guidewire to
re-enter the true lumen distally of the lesion.
Materials
Stingray LP Catheters have a polymer shaft with hydrophilic coating and platinum
iridium marker bands.
Non-Pyrogenic
The Stingray LP is non-pyrogenic.
User Information
Physicians thoroughly trained in interventional cardiology procedures.
LP
INTENDED USE / INDICATIONS FOR USE
The Stingray LP Catheter is indicated for directing, steering, controlling, and supporting
a guidewire in order to access discrete regions of the coronary vasculature.
When used as part of the System consisting of the CrossBoss
Catheter and Stingray Guidewire, the Stingray LP Catheter is indicated for use to facilitate
the intraluminal placement of conventional guidewires beyond stenotic coronary
lesions (including chronic total occlusions [CTOs]) prior to PTCA or stent intervention.
CLINICAL BENEFIT STATEMENT
The clinical benefit of the Stingray LP Catheter is its ability to facilitate placement of
a guidewire beyond a stenotic coronary lesion as part of a percutaneous coronary
intervention (PCI) to improve myocardial perfusion in patients who are candidates for
PCI procedures.
SUMMARY OF SAFETY AND CLINICAL PERFORMANCE
For customers in the European Union, use the device name found in the labeling
to search for the device's Summary of Safety and Clinical Performance, which is
available on the European database on medical devices (EUDAMED) website:
(https://ec.europa.eu/tools/eudamed).
CONTRAINDICATIONS
• Not intended for use in the cerebral vasculature.
• Unprotected left main coronary artery.
• Coronary artery spasm in the absence of a significant stenosis.
WARNINGS
• Only physicians thoroughly trained in interventional cardiology procedures should
use the Stingray LP Catheter.
• To reduce the potential for vessel damage, the inflated balloon should only be used
in vessels that are ≥2.5 mm in diameter as measured proximal and distal to the
inflation site.
• Balloon pressure should not exceed the rated burst pressure. Use of a pressure
monitoring device is recommended to prevent over pressurization.
• Use only the recommended balloon inflation medium.
• Do not advance or retract the Stingray LP Catheter unless the balloon is fully
deflated under vacuum.
• Pay special attention when directing a guidewire out a side port. Never push, withdraw
or torque components that meet resistance. Device kinking, breaking, or vessel damage
may occur. Fluoroscopy should always be used to aid device manipulation.
• Used devices may pose a biohazard risk and must be handled and disposed of properly.
PRECAUTIONS
• Use prior to the Expiration Date.
• The Stingray LP Catheter should only be used in hospitals where emergency
coronary bypass surgery can be immediately performed in the event of a
potentially injurious or life-threatening complication.
• Before insertion of the catheter, administer appropriate anticoagulant and
vasodilator therapy.
• The Stingray LP Catheter should be handled with care. Prior to use and during the
procedure, inspect the packaging and catheter for bends, kinks, or other damage.
Discontinue use if the catheter becomes damaged.
3
™ Catheter, Stingray LP
Black (K) ∆E ≤5.0