Boston Scientific Stingray LP Instrucciones De Uso página 4

• Do not expose to organic solvents.
• Always use wire support for advancement, manipulations, and withdrawal of the
Stingray LP Catheter.
• The Stingray LP Catheter should only be manipulated under fluoroscopic observation.
ADVERSE EVENTS
Potential adverse events include, but are not limited to, the following:
• Acute myocardial infarction
• Artery spasm
• Cardiac tamponade
• Death
• Drug reactions, allergic reaction to contrast media
• Embolism
• Hemorrhage or hematoma
• Infection
• Prolonged procedure or the need for additional intervention
• Radiation injury
• Recurrence of angina
• Stroke/neurological deficit
• Vessel trauma
HOW SUPPLIED
Device Details
Contents supplied STERILE using an ethylene oxide (EO) process.
Do not use if package is damaged or unintentionally opened before use.
If damage is found, call your Boston Scientific representative.
Do not use if labeling is incomplete or illegible.
Handling and Storage
This product has no special handling or storage requirements.
OPERATIONAL INSTRUCTIONS
Additional Items for Safe Use
The following supplies are not provided and need to be available and prepped prior to
use of the Stingray LP Catheter:
• Femoral or radial guide catheter access to the target vessel, minimum
I.D. = 0.070 in (1.7 mm)
• Angiographic imaging supplies (i.e. radiopaque contrast, manifold, tubing, etc.)
• Sterile heparinized normal saline
• Stingray Guidewire
• Stingray Extension Wire as needed
• Inflation device with manometer
• Systemic anticoagulation and antithrombotic therapy
• Other supplies as needed to complete the established laboratory protocol
Product Preparation
1. Remove the Stingray LP Catheter from the sterile packaging.
2. Remove the balloon protector and stylet.
Black (K) ∆E ≤5.0
3. Flush the guidewire lumen with saline.
4. Ensure all device surfaces are exposed to heparinized and sterile saline.
5. Prepare balloon with either method 1 or 2 below:
Prep method 1:
a. Prepare a 1:1 mixture of contrast medium and sterile saline.
b. Aspirate 3 cm³ – 4 cm³ (3 cc – 4 cc) of contrast mixture into a 20 cm³ (20 cc) or
larger syringe and purge air from the syringe barrel.
c. Attach the syringe to a female luer lock on a 3-way stopcock and fill the stopcock
lumens with contrast medium mixture.
d. Attach the 3-way stopcock and syringe to the Stingray LP Catheter inflation port.
e. Hold the syringe with the nozzle pointing downward and aspirate for 5 seconds.
f. Close the Stingray LP Catheter inflation port with the 3-way stopcock, remove
the syringe, and evacuate air from the barrel.
g. Reconnect the syringe to the 3-way stopcock and purge the 3-way stopcock.
h. Open the stopcock, aspirate until bubbles no longer appear, release the plunger,
and disconnect the syringe from the 3-way stopcock.
Prep method 2:
a. Connect a new/unused stopcock to a new/unused 20 cm³ (20 cc) syringe and
close stopcock side-port.
b. Connect Stingray LP Catheter inflation port to stopcock.
c. Hold the syringe with the nozzle pointing downward and aspirate for 15 seconds.
d. Close stopcock to Stingray LP Catheter.
e. Remove the syringe and evacuate all air from the barrel.
f. Reconnect the syringe to the stopcock and close the side-port.
g. Hold the syringe with the nozzle pointing downward and aspirate for 15 seconds.
h. Close stopcock to Stingray LP Catheter and remove the syringe.
i. Fill 3 cm³ (3 cc) syringe with 3 cm³ (3 cc) of 100% contrast.
j. Purge air from 3 cm³ (3 cc) syringe.
k. Connect 3 cm³ (3 cc) syringe to stopcock and purge air from stopcock.
l. Open stopcock between 3 cm³ (3 cc) syringe and Stingray LP Catheter to allow
contrast to draw into Stingray LP Catheter.
m. Close stopcock to Stingray LP Catheter and remove 3 cm³ (3 cc) syringe.
6. Prepare a balloon inflation device according to the manufacturer's instructions.
Product Operation
1. Access the vascular system and place the appropriate size introducer sheath per
manufacturer's instructions.
2. Engage the vessel to be treated with an appropriate guiding catheter per
manufacturer's instructions. Connect a hemostatic Y-adapter to the guiding
catheter hub.
3. Assure the Stingray LP Catheter has been prepped per instructions.
4. Remove the appropriate guidewire from its package and inspect for damage.
5. Advance the guidewire to the target location using fluoroscopic guidance.
6. Back-load the Stingray LP Catheter onto the proximal portion of the guidewire.
7. Loosen the knob on the hemostatic Y-adapter.
8. Track the Stingray LP Catheter over the wire and into the proximal guiding
catheter lumen.
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