Medtronic 105-5083-153 Instructions for Use

INSTRUCTIONS FOR USE
Rebar Micro Catheter
TABLE OF CONTENTS
Rebar™ Micro Catheter
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Symbol Glossary .............................................7
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English en
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Instructions for Use
CAUTIONS
Federal (USA) law restricts this device to sale, distribution, and use by or on the order of a physician.
This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.
DESCRIPTION
The Rebar™ Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter shaft has a hydrophilic coating that spans the distal portion of the catheter to reduce the friction during use: 130 cm catheter with 85 cm hydrophilic coating, 145 cm catheter with 95 cm hydrophilic coating, and 153 cm catheter with 100 cm hydrophilic coating. The catheter has a semi-rigid proximal shaft which transitions into the exible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate uoroscopic visualization. The outer surface of the catheter is coated to increase lubricity. The Rebar™ Micro Catheter is packaged with a tip shaping mandrel.
1. Distal outer diameter
2. Usable length
3. Proximal outer diameter
4. Inner diameter
2
3
Figure 1. Rebar™ Micro Catheter
5. Overall length
6. Marker band outer diameter
7. Marker band distance
*Applicable to CFN 105-5081-153 only
6
7*
1
4
DEVICE COMPATIBILITY
Refer to product label and Table 1 for device dimensions. Refer to labeling provided with other medical technologies to determine compatibility.
INTENDED PURPOSE / INDICATIONS FOR USE
The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
CONTRAINDICATIONS
It is not intended for use in the coronary vasculature.
The Rebar™ Micro Catheter is contraindicated when, in the medical judgment of the physician, such a procedure may compromise the patient’s condition.
The Rebar™ Micro Catheter is contraindicated for neonatal and pediatric use.
DIRECTIONS FOR USE
NOTE: See package insert for Rebar™ Micro Catheter functional characteristics.
1. Place the appropriate guide catheter following recommended procedures. Connect a one-way stop-cock to the guide catheter to prevent backow of blood during insertion of catheter. Connect a hemostatic side arm adapter one way stop-cock to allow for insertion of catheter and to continuously ush the guide catheter with saline. NOTE: It is recommended that a guide catheter with a minimum internal diameter of 0.053” be used with the Rebar™ Micro Catheter.
2. Gently remove the packaging coil for the Rebar™ Micro Catheter from the pouch.
3. Flush the coil with heparinized saline through the female luer attached to the coil.
4. Flush the ID of the catheter with heparinized saline by attaching a saline lled syringe to the catheter hub.
5. Remove the appropriate steerable guidewire from its packaging and inspect for damage. Follow manufacturer’s instructions for preparing and using the guidewire.
6. Carefully insert guidewire into the hub of the Rebar™ Micro Catheter and advance into the catheter lumen.
7. Remove the micro catheter by removing the hub from the clip and gently pulling on the hub.
8. Inspect the catheter prior to use to verify that it is undamaged. Retain the packaging coil for storage of the catheter when it is not in use during the procedure.
9. Close the one-way stop-cock.
10. Loosen the hemostatic valve.
Product
Name
Rebar™ 18
Micro Catheter
Rebar™ 18
Micro Catheter
Rebar™ 18
Micro Catheter
Rebar™ 27
Micro Catheter
Rebar™ 27
Micro Catheter
CFN
105-5081-130 Single
105-5081-153* D ual
105-5083-153 Single
105-5082-130 Single
105-5082-145 Single
Marker
band
Distal outer
diameter
(1)
2.4 F
0.031” (0.81 mm)
2.4 F
0.031” (0.81 mm)
2.4 F
0.031” (0.81 mm)
2.8 F
0.037” (0.94 mm)
2.8 F
0.037” (0.94 mm)
Table 1. Dimensions for Rebar™ Micro Catheter
Usable length
130 cm
153 cm
153 cm
130 cm
145 cm
(2)
Proximal outer
diameter
(3)
2.7 F
0.035” (0.91 mm)
2.7 F
0.035” (0.91 mm)
2.7 F
0.035” (0.91 mm)
2.8 F
0.037” (0.94 mm)
2.8 F
0.037” (0.94 mm)
Inner diameter
0.021” (0.53 mm) 137 cm
0.021” (0.53 mm) 160 cm
0.021” (0.53 mm) 160 cm
0.027” (0.69 mm) 135 cm
0.027” (0.69 mm) 150 cm
Overall
(4)
length
(5)
Marker band
outer diameter
(6)
2.4 F
0.031” (0.81 mm)
2.4 F
0.031” (0.81 mm)
2.4 F
0.031” (0.81 mm)
2.8 F
0.037” (0.94 mm)
2.8 F
0.037” (0.94 mm) - 0.67 ml
Marker band
distance
(7*)
- 0.42 ml
3 cm 0.49 ml
- 0.49 ml
- 0.61 ml
Dead space
volume
Max.
Guidewire
0.018”
(0.46 mm)
0.018”
(0.46 mm)
0.018”
(0.46 mm)
0.021”
(0.53 mm)
0.021”
(0.53 mm)
3
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