Teleflex ARROW GlideThru, Manual

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GlideThru™ Peel-Away Sheath/Dilator
Introducer
Rx only.
Indications for Use:
The Arrow® GlideThru™ Peel-Away Sheath/Dilator Introducer is used for percutaneous
introduction of diagnostic or therapeutic devices into the vasculature.
Contraindications:
None known.
Clinical Benefits to be Expected:
Permits venous access for catheter introduction.
General Warnings and Precautions
Warnings:
1. Sterile, Single use: Do not reuse, reprocess or resterilize.
Reuse of device creates a potential risk of serious injury
and/or infection which may lead to death. Reprocessing of
medical devices intended for single use only may result in
degraded performance or a loss of functionality.
2. Read all package insert warnings, precautions and
instructions prior to use. Failure to do so may result in severe
patient injury or death.
3. Clinicians must be aware of complications/undesirable
side-effects associated with vascular access including but
not limited to:
•
vessel perforation
•
sheath embolus
•
intravascular device
related infection
•
mediastinal injury
•
air embolism
•
vessel wall damage/
thrombosis
•
inadvertent arterial
puncture
•
nerve damage
•
hematoma
•
hemorrhage
4. Do not leave peel-away sheath/dilator in place as an
indwelling catheter. Leaving peel-away sheath/dilator in
place puts patient at risk for possible vessel wall perforation.
5. Do not use excessive force when introducing guidewire,
peel-away sheath over tissue dilator, or tissue dilator as this
can lead to vessel perforation and bleeding.
Precautions:
1. Do not alter the assembly except as instructed during
procedure steps.
2. Procedure must be performed by trained personnel well
versed in anatomical landmarks, safe technique, and
potential complications.
3. Use standard precautions and follow institutional policies for
all procedures including safe disposal of devices.
A Suggested Procedure:
Use sterile technique.
1. Ensure dilator is in position and locked to hub of sheath.
2. Thread peel-away sheath/dilator assembly over guidewire.
3. Grasping near skin, advance peel-away sheath/dilator assembly over guidewire with
slight twisting motion to a depth sufficient to enter vessel.
4. If necessary, enlarge cutaneous puncture site with cutting edge of scalpel, positioned
away from guidewire.
Warning: Do not cut guidewire to alter length.
Warning: Do not cut guidewire with scalpel.
• Position cutting edge of scalpel away from guidewire.
• Engage safety and/or locking feature of scalpel (when applicable) when not in use
to reduce the risk of sharps injury.
Precaution: Do not withdraw dilator until sheath is well within vessel to reduce
risk of damage to sheath tip.
Precaution: Sufficient guidewire length must remain exposed at hub end of
sheath to maintain a firm grip on guidewire.
5. Check peel-away sheath placement by holding sheath in place, twist dilator hub
counterclockwise to release dilator hub from sheath hub, withdraw guidewire and
dilator sufficiently to allow blood flow.
6. Holding sheath in place, remove guidewire and dilator as a unit (refer to Figure 1).
Figure 1 Figure 2
Warning: Do not apply undue force on guidewire to reduce risk of possible
breakage.
Warning: Do not leave tissue dilator in place as an indwelling catheter. Leaving
tissue dilator in place puts patient at risk for possible vessel wall perforation.
7. Quickly occlude sheath end upon removal of dilator and guidewire to reduce risk of
air entry.
Warning: Do not leave open dilators or sheaths uncapped in venous puncture site.
Air embolism can occur if air is allowed to enter a vascular access device or vein.
8. Verify entire guidewire is intact upon removal.
9. Insert catheter through peel-away sheath to final indwelling position.
10. Withdraw peel-away sheath over catheter until sheath hub and connected portion of
sheath is free from venipuncture site. Grasp tabs of peel-away sheath and pull away
from the catheter (refer to Figure 2), while withdrawing from vessel until sheath splits
down its entire length.
Precaution: Avoid tearing sheath at insertion site which opens surrounding
tissue creating a gap between catheter and dermis.
11. If catheter migrated during sheath removal, re-advance catheter to final indwelling
position.
For reference literature concerning patient assessment, clinician education,
insertion technique, and potential complications associated with this procedure,
consult standard textbooks, medical literature, and Arrow International LLC website:
www.teleflex.com