Potential Adverse Events - Medtronic Micra Nstrucciones De Uso

M953967A_ch.fm 9/25/13 4:13 pm
4.5" x 10.875" (114 mm x 276 mm)
M953967A002D.book Page 5 Wednesday, September 25, 2013 4:13 PM
Micra Introducer
Introducer Sheath with Hydrophilic Coating
1 Device Description
The Micra introducer (Figure 1) is a single-use, disposable, hydrophilically coated sheath that provides a
flexible and hemostatic conduit for the insertion of intravascular devices into the venous system to minimize
blood loss. The system is comprised of 2 components: a dilator that accommodates a 0.035 in (0.89 mm)
guidewire and an introducer.
The dilator is radiopaque and has a tapered, flexible tip that facilitates atraumatic tracking through the
vasculature. A female luer taper fitting is located on the proximal end of the dilator grip. The distal end of the
dilator grip is threaded to allow the dilator to be secured to the sheath seal housing.
The introducer is comprised of a hydrophilically coated, coil-reinforced sheath that is attached to a rigid seal
housing containing the hemostatic valve assembly. A sideport extension with a 3-way valve is permanently
attached to the seal housing. A radiopaque markerband is located at the distal tip of the sheath. The
introducer also has a suture loop for attaching it to the patient and a strain relief to prevent kinking of the
sheath where it joins to the seal housing.
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1 Dilator grip female luer taper thread
2 Dilator grip
3 Seal housing with hemostatic valve assembly (sheath hub)
4 Strain relief
5 Suture loop
6 Sideport extension with 3-way valve
7 Introducer
8 Introducer sheath
9 Dilator
10 Dilator tapered tip
Figure 1. Micra introducer sheath
Note: Graphical representation not drawn to scale.
This device does not contain natural rubber latex; however, during the manufacturing process, it may have
incidental contact with latex.
2 Indications for Use
The Micra introducer is intended to provide a conduit for the insertion of devices into the venous system and
to minimize blood loss associated with such insertions.
3 Contraindications
There are no known contraindications with this device. It is not intended for use except as indicated.
4 Warnings and Precautions
Caution: Read all instructions carefully. Failure to properly follow the instructions, warnings, and precautions
may lead to serious consequences or injury to the patient.
Do not alter this device. Alterations may impair device function.
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Do not cut or puncture the sheath. This could result in major blood loss and vessel trauma.
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Do not use after the Use By date printed on the label.
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This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product.
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Reuse, reprocessing, or resterilization may compromise the structural integrity of the device or create a
risk of contamination of the device, which could result in patient injury, illness, or death.
After use, dispose of the device in accordance with hospital, administrative, or government policies.
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The dilator is only compatible with a 0.035 in (0.89 mm) guidewire.
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Verify sheath, device, catheter, and accessory components size compatibility prior to use. The maximum
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diameter and length of the instrument or catheter to be introduced should be determined to ensure its
passage through the sheath. Introduction of a smaller intravascular device may result in increased blood
loss. Note: The length of the sheath does not include the strain relief.
If scar tissue is present, predilatation may be required.
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Adequate vessel access is required to introduce the sheath into the vasculature. Careful evaluation of
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vessel size, anatomy, tortuosity, and disease state (including calcification, plaque, and thrombus) is
required to ensure successful sheath introduction and subsequent withdrawal. If vessel is not adequate
for access, major bleeding, vessel damage, or serious injury to the patient, including death, may result.
If vessel size is smaller than the introducer sheath's outer diameter, major bleeding, vessel damage, or
serious injury to the patient, including death, may result.
When inserting, manipulating, or withdrawing a device through the sheath, always maintain sheath
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position.
When puncturing, suturing, or incising the tissue near the sheath, use caution to avoid damaging the
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sheath.
Do not attempt to insert or withdraw the introducer sheath if resistance is felt. The cause of the resistance
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must be determined before proceeding.
Do not attempt to simultaneously insert multiple catheters or interventional devices into the sheath.
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Advance and withdraw the sheath (with the dilator fully inserted and locked in) only under fluoroscopic
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guidance.
Ensure that the dilator is fully inserted into the introducer to minimize the risk of vascular injury.
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5 Adverse Events

5.1 Potential Adverse Events

Adverse events or complications associated with use of the Micra introducer include, but are not limited to:
allergic response to materials
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blood loss, bleeding, or hematoma
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embolization (micro or macro) with transient or permanent ischemia
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infection
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vascular trauma (eg, dissection, rupture, perforation, or tear)
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death
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M953967A002 Rev D
Medtronic Confidential
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Refer to document # M953967A for
Printing Instructions.
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