Adverse Events - Medtronic InTRAkit Instrucciones De Uso

2016/JUN/06 at 11:44 a.m. Doc number: M057366T001 Rev. 1C [global]
Printspec i - 4.0 x 11.0 inches
■
Do not turn the stopcock more than 180 degrees.
■ Use the mini-guidewire only to advance the introducer-sheath–vessel-dilator
assembly.
■
Do not use sharp-edged tools or forceps on the introducer sheath or sideport
tubing.
■
The entire procedure must be performed aseptically.
■ Do not use open or damaged packages.
■
After use, this product may be a potential biohazard. Handle and dispose of all
such devices in accordance with accepted medical practice and applicable
local, state, and federal laws and regulations.

6. Adverse Events

Adverse events that may occur or require intervention include, but are not limited
to, the following:
■ Air embolism or thrombus formation
■
Arterial spasm
■ Hematoma
7. Instructions for Use
7.1. Preparation
1. Remove components from package.
2. Flush all components with heparinized saline solution.
Warning: Failure to flush the device prior to use may result in an embolus.
3. Fully insert the vessel dilator into the introducer sheath and snap it to the
sheath hub.
Warning: Insert the vessel dilator into the center of the hemostasis valve of the
introducer sheath. Do not force vessel dilator insertion as it may cause damage
to the introducer sheath valve and vessel dilator.
4. Activate the hydrophilic coating on the introducer sheath by wetting the outer
surface of the introducer-sheath–vessel-dilator assembly with heparinized
saline solution.
Note: Ensure the stopcock on the introducer sheath hub is in the closed
position prior to the procedure.
7.2. Procedure
Note: If necessary, make a skin incision to the access site to allow for smooth
insertion of the introducer-sheath–vessel-dilator assembly.
Note: Apply anticoagulant therapy to the patient.
1. Orient the needle such that the bevel indicator on the needle hub is facing
upwards (Figure 2).
Figure 2. Orienting the Needle
2. Insert the micropuncture needle or IV catheter into the target vessel using
accepted medical technique.
3. If using the IV catheter, hold the hub of the plastic IV cannula in place and
remove the needle. Leave the IV cannula in the target vessel.
4. Confirm introduction by observing the presence of blood flashback.
5. Insert the flexible tip of the mini-guidewire through the micropuncture needle or
the IV cannula and into the vessel.
Caution: If using a micropuncture needle, do not withdraw the mini-guidewire
through the needle.
Caution: Advance the mini-guidewire slowly and carefully to avoid damage to
the vessel wall. If resistance is met, do not advance or withdraw the mini-
guidewire until the cause of resistance has been determined.
6. Once the mini-guidewire has been successfully introduced into the target
vessel, remove the micropuncture needle or IV cannula over the mini-guidewire
while holding the mini-guidewire in place.
7. Advance the introducer-sheath–vessel-dilator assembly over the mini-
guidewire and into the vessel.
Note: Ensure the vessel dilator remains firmly snapped to the introducer
sheath during insertion.
Note: If needed, remove the mini-guidewire and use the vessel dilator hub as
an injection or sampling port before removing the vessel dilator.
8. Withdraw the mini-guidewire and vessel dilator slowly and carefully, leaving the
introducer sheath in the vessel.
Caution: After removing the vessel dilator and mini-guidewire, use caution if
advancing the introducer sheath, as doing so may cause damage to the vessel.
9. The access site may now be used for the intravascular procedure. Hold the
introducer sheath in place when inserting, positioning, or removing a catheter.
If necessary, use the suture groove to suture the introducer sheath in place.
4 Instructions for Use English
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■ Infection
■
Intimal tear
■ Vessel perforation