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INSTRUCTIONS FOR USE
Rebar™ Micro Catheter
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TABLE OF CONTENTS
Rebar™ Micro Catheter
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Symbol Glossary .............................................7
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Instructions for Use
Rebar™ Micro Catheter
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
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Figure 1. Rebar™ Micro Catheter
5. Overall length
6. Marker band outer diameter
7. Marker band distance
*Applicable to CFN 105-5081-153 only
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7*
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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 backow 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)
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11. Introduce the guidewire and micro catheter as a unit through the hemostatic sidearm adapter into the
lumen of the guiding catheter. Advance guidewire/catheter assembly to the distal tip of the guiding
catheter.
12. Tighten the valve around the micro catheter to prevent backow, but allowing some movement
through the valve by the micro catheter.
13. Open the one-way stop-cock.
14. Alternatively advance the guidewire and micro catheter until the desired site has been reached.
NOTE: To facilitate catheter handling the proximal portion of the micro catheter is uncoated to ensure
a non-slip grip.
15. When ready to infuse, withdraw the guidewire completely from the Rebar™ Micro Catheter. Connect a
syringe containing infusate to the micro catheter hub, and infuse as required.
16. After completing the procedure, withdraw the micro catheter and discard.
Steam Shaping Mandrel
In order to maintain catheter integrity and dimensional stability of the inner diameter, it is recommended
that the user follow these instructions.
WARNINGS
• Shaping Mandrel is not intended for use in the human body.
• Use only a steam source to shape the catheter tip. Do not use other heat sources.
• Prior to use, inspect the catheter tip for any damage that may have resulted from shaping. Do not
use a catheter that has been damaged in any way. Damaged catheters may rupture causing vessel
trauma or tip detachment during steering maneuvers.
1. Remove shaping mandrel from card and insert into distal tip of the catheter.
2. Carefully bend catheter tip and shaping mandrel to desired shape. A slight over exaggeration of the
shape may be required to accommodate for catheter relaxation.
3. Shape the catheter by holding the shaped portion approximately 1 inch (2.5 cm not less than 1 cm)
from the steam source for about 20 seconds (DO NOT EXCEED 30 SECONDS.)
4. Allow catheter tip to cool in air or saline prior to removing mandrel.
5. Remove mandrel from catheter and discard. Multiple shaping is not recommended.
6. Inspect the tip for any damage that may have resulted from steam shaping the catheter tip. If any
damage is found, do not use the catheter.
Functional Characteristics
Flow Rates @ 100 PSI (690 kPa) and 300 PSI (2,070 kPa) – ml/sec
Saline
Pressure 100 300 100 300 100 300 100 300
Rebar™ 18
105-5083-153 0.9 1.5 0.4 1.0 0.2 0.6 0.1 0.3
105-5081-153 0.9 1.5 0.4 1.0 0.2 0.6 0.1 0.3
105-5081-130 0.9 1.7 0.5 1.1 0.2 0.7 0.1 0.4
Rebar™ 27
105-5082-145 1.4 2.5 0.6 1.8 0.3 1.3 0.2 0.7
105-5082-130 1.8 3.0 1.1 2.6 0.7 1.7 0.3 0.9
All Rebar™ Micro Catheters have a maximum allowable dynamic pressure of 700 PSI (4,830 kPa) and static pressure of 300
PSI (2,070 kPa). Flow rate values may vary depending on contrast media and mixture ratios used. Rebar™ 27 ow rate
testing was performed with Conray (60% Ionic) and MD-76R (70% Ionic) contrast for user reference.
76% Contrast/ Saline
(50/50)
60% Ionic Contrast 76% Ionic Contrast
Catheter Retrieval Instructions
PRECAUTIONS
• If catheter entrapment is suspected (with an embolic agent), fast catheter retrieval technique may
result in catheter shaft separation and potential vascular damage.
1. Slowly remove any ‘slack’ in the distal catheter shaft.
2. Gently and slowly apply 3-5 cm traction to the catheter to begin catheter retrieval.
3. Should catheter removal become dicult, the following will assist in catheter retrieval. Assess the
following parameters by observing the distal shaft of the catheter:
• Vessel straightening
• Traction on embolic cast
• Catheter tip releasing from embolic cast
4. Further traction (of 3-5 cm) may be applied gently if necessary to transfer distal catheter shaft.
• Hold this traction for a few seconds and release
• Assess traction of vasculature to minimize risk of hemorrhage
5. This process can be repeated intermittently until catheter is retrieved.
NOTE: Do not apply more than 20 cm of traction to catheter to minimize risk of catheter separation.
6. Under some dicult clinical situations, it may be safer to leave a micro catheter in the
vascular system rather than risk rupturing the malformation and, consequently a hemorrhage,
by exercising too much traction on an entrapped catheter.
This is accomplished by stretching the catheter and cutting the shaft near the entry point of vascular
access allowing the catheter to remain in the artery.
If catheter breaks during removal, distal migration or coiling of the catheter may occur. Same
day surgical resection should be considered to minimize risk of thrombosis.
POTENTIAL COMPLICATIONS
Potential complications of the device and the endovascular procedure include or are synonymous with, but
may not be limited to:
• Access site complications such as
hematoma, pain, hemorrhage, skin
discoloration, nerve damage, abscess
• Adverse reactions to antiplatelet/
anticoagulation agents, contrast
media, or anesthesia such as
coagulopathy, organ failure,
aspiration, nausea, hypotension
• Cardiac complications such as
arrhythmia
• Complications of radiation exposure
such as alopecia, burns ranging in
severity from skin reddening to ulcers,
cataracts, and delayed neoplasia
*Consult instructions for use for other therapy devices and medications for additional potential complication
information. If a serious incident related to the device occurs, contact your Medtronic representative and the
competent authority in your respective country/region.
• Device malfunctions such as device fracture, device
migration, friction, foreign body in patient
• Hematologic complications such as thrombosis,
thromboembolism, embolism, gas embolism,
hemolysis, intracranial hemorrhage
• Neurological decits including stroke and death
• Systemic complications such as fever, infection,
inammation, edema, shock, toxicity, foreign body
reaction, hypersensitivity, organ failure
• Therapeutic response decreased
• Vascular complications such as dissection,
perforation, rupture, ischemia, vasospasm,
stenosis, necrosis, granuloma, stula, occlusion
WARNINGS
• Infusion pressure with this device should not exceed pressure as specied in the package insert.
Excess pressure may result in catheter rupture, which may result in patient injury.
• If ow through the micro catheter becomes restricted, do not attempt to clear the device by high
pressure infusion. Either remove the micro catheter to determine the cause of the obstruction or
replace it with a new micro catheter. Excessive pressure may cause catheter rupture, which may
result in patient injury.
• Never advance or withdraw an intraluminal device against resistance until the cause of the
resistance is determined by uoroscopy. Excessive force against resistance may result in damage
to the device or vessel perforation.
• This device is intended for single use only. Do not reprocess or re-sterilize. Reprocessing and resterilization increase the risks of patient infection and compromised device performance.
• Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do
not use the device if breaches in sterile barrier system integrity are evident.
• For additional Materials of Concerns information such as REACH, CA Prop 65 or other product
stewardship programs, go to www.medtronic.com/productstewardship
PRECAUTIONS
• Prior to use, carefully examine the Rebar™ Micro Catheter and its packaging to verify that it has not
been damaged during shipment.
• Embolic agents must be used in accordance with manufacturer’s instructions.
• Prior to use, all accessory devices and agents should be fully prepared according to the manufacturer’s
instructions.
• Always monitor infusion rates when using this micro catheter.
• The micro catheter has a lubricious hydrophilic coating on the outside of the catheter. It must be kept
hydrated in order to be lubricious. This can be accomplished by attaching a Y-connector to a continuous
saline drip.
• When injecting contrast for angiography, ensure that the catheter is not kinked or occluded.
• When the infusion catheter is in the body, it should be manipulated only under uoroscopy. Do not
attempt to move the catheter without observing the resultant tip response.
• Because the Rebar™ Micro Catheter may be easily advanced into narrow, selective vasculature,
repeatedly verify (for example by slightly withdrawing the catheter) that the Rebar™ Micro Catheter
has not been advanced so far as to interfere with its removal.
• Operators should take all necessary precautions to limit X-radiation doses to patients and themselves
by using sucient shielding, reducing uoroscopy times, and modifying X-ray technical factors where
possible.
HOW SUPPLIED
• This device is supplied STERILE using ethylene oxide. This device is Non-pyrogenic.
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STORAGE AND DISPOSAL
• This device should be stored in a dry place, away from sunlight.
• Dispose of device in accordance with hospital, administrative, and/or local government policy.
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Symbol Glossary
Sterilized using ethylene oxide
Do not re-use
Caution: Federal (USA) law restricts this device to sale by or on the order
of a physician
Do not resterilize
Consult instructions for use at this website
Caution
Do not use if package is damaged
Keep dry
Catalogue number
Manufacturer
Use-by date
Batch code
Contents of Package
Non-pyrogenic
Keep away from sunlight
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M016960CDOC2 Rev. A (03/2021)
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