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Idiomas disponibles
Idiomas disponibles
GB
GB
Sterilized using irradiation
Sterilized using irradiation
Do not re-sterilize
Do not re-sterilize
Do not re-use
Do not re-use
Use by
Use by
I. DESCRIPTION
I. DESCRIPTION
(See picture 1)
(See picture 1)
The FoxCross Percutaneous Transluminal Angioplasty (PTA) Catheter is a dual
The FoxCross Percutaneous Transluminal Angioplasty (PTA) Catheter is a dual
lumen catheter with a balloon (1) located near the distal atraumatic tip (2). One
lumen catheter with a balloon (1) located near the distal atraumatic tip (2). One
lumen is used for inflating the balloon and is accessed via the side leg part (3). The
lumen is used for inflating the balloon and is accessed via the side leg part (3). The
second lumen, starting at the straight entry port (4), allows access to the distal tip of
second lumen, starting at the straight entry port (4), allows access to the distal tip of
the catheter for guidewire insertion(max 0.035") and pressure monitoring. The
the catheter for guidewire insertion(max 0.035") and pressure monitoring. The
balloon has two radiopaque markers (5 & 6) for positioning the balloon relative to
balloon has two radiopaque markers (5 & 6) for positioning the balloon relative to
the stenosis. The radiopaque marker bands indicate the dilating section of the
the stenosis. The radiopaque marker bands indicate the dilating section of the
balloon and help in balloon placement.
balloon and help in balloon placement.
Picture 1
Picture 1
The balloon is dilated using the side leg part (3), at which the balloon expands to a
The balloon is dilated using the side leg part (3), at which the balloon expands to a
known diameter at specific pressure. The working pressure range for the balloon is
known diameter at specific pressure. The working pressure range for the balloon is
between the nominal size pressure and the rated burst pressure. All balloons
between the nominal size pressure and the rated burst pressure. All balloons
distend to sizes above the nominal diameter at pressures greater than the nominal
distend to sizes above the nominal diameter at pressures greater than the nominal
pressure.
pressure.
The compatible guidewire size is printed on the manifold (7); balloon diameter and
The compatible guidewire size is printed on the manifold (7); balloon diameter and
length are printed on the luer (8). Refer also to the package label for information
length are printed on the luer (8). Refer also to the package label for information
about catheter length, nominal and rated burst pressure, and sheath compatibility.
about catheter length, nominal and rated burst pressure, and sheath compatibility.
How the system is supplied
How the system is supplied
The FoxCross is supplied sterile and is intended for one-time use only. This single
The FoxCross is supplied sterile and is intended for one-time use only. This single
use device cannot be reused on another patient, as it is not designed to perform as
use device cannot be reused on another patient, as it is not designed to perform as
intended after the first usage. Changes in mechanical, physical, and/or chemical
intended after the first usage. Changes in mechanical, physical, and/or chemical
characteristics introduced under conditions of repeated use, cleaning, and/or
characteristics introduced under conditions of repeated use, cleaning, and/or
resterilization may compromise the integrity of the design and/or materials, leading
resterilization may compromise the integrity of the design and/or materials, leading
to contamination due to narrow gaps and/or spaces and diminished safety and/or
to contamination due to narrow gaps and/or spaces and diminished safety and/or
performance of the device. Absence of original labeling may lead to misuse and
performance of the device. Absence of original labeling may lead to misuse and
eliminate traceability. Absence of original packaging may lead to device damage,
eliminate traceability. Absence of original packaging may lead to device damage,
loss of sterility, and risk of injury to the patient and/or user.
loss of sterility, and risk of injury to the patient and/or user.
Packaged with every FoxCross is a protective tubing that is positioned over the
Packaged with every FoxCross is a protective tubing that is positioned over the
balloon.
balloon.
Storage
Storage
The FoxCross should be stored in a dark, dry and cool place. Do not expose to
The FoxCross should be stored in a dark, dry and cool place. Do not expose to
organic solvents, ionizing radiation or
organic solvents, ionizing radiation or
ultraviolet light. Rotate inventory so that the device is used prior to the use by date
ultraviolet light. Rotate inventory so that the device is used prior to the use by date
on the package label.
on the package label.
II. INDICATIONS
II. INDICATIONS
Percutaneous transluminal angioplasty with the use of the FoxCross is indicated in,
Percutaneous transluminal angioplasty with the use of the FoxCross is indicated in,
but may not be limited to, the narrowing of the following vessels:
but may not be limited to, the narrowing of the following vessels:
– lower limb
– lower limb
– pelvic
– pelvic
– renal
– renal
III. CONTRAINDICATIONS
III. CONTRAINDICATIONS
– Inability to cross lesion with a guide wire.
– Inability to cross lesion with a guide wire.
– The FoxCross is contraindicated for use in the central circulation system, in
– The FoxCross is contraindicated for use in the central circulation system, in
accordance with guideline MDD 93/42.
accordance with guideline MDD 93/42.
IV. WARNINGS / PRECAUTIONS
IV. WARNINGS / PRECAUTIONS
– This device should only be used by physicians who are experienced and have a
– This device should only be used by physicians who are experienced and have a
thorough understanding of the clinical and technical aspects of PTA.
thorough understanding of the clinical and technical aspects of PTA.
– One-time use only – do not resterilize! The catheters are extremely difficult to
– One-time use only – do not resterilize! The catheters are extremely difficult to
clean adequately after being exposed to biological materials and may cause
clean adequately after being exposed to biological materials and may cause
adverse patient reactions if reused. Cleaning these products may alter their
adverse patient reactions if reused. Cleaning these products may alter their
structural properties. Accordingly, Abbott Vascular will not be responsible for any
structural properties. Accordingly, Abbott Vascular will not be responsible for any
direct, incidental or consequential damage resulting from reuse or resterilization
direct, incidental or consequential damage resulting from reuse or resterilization
of the catheter.
of the catheter.
– Do not use if inner package is damaged or opened.
– Do not use if inner package is damaged or opened.
– Use prior to the use by date.
– Use prior to the use by date.
– Carefully inspect the catheter prior to use to verify that it has not been damaged
– Carefully inspect the catheter prior to use to verify that it has not been damaged
during shipment and that its size, shape and condition are suitable for the
during shipment and that its size, shape and condition are suitable for the
procedure for which it is to be used.
procedure for which it is to be used.
– Precautions to prevent or reduce clotting should be taken when any catheter is
– Precautions to prevent or reduce clotting should be taken when any catheter is
used. Flush or rinse all products entering the vascular system with sterile isotonic
used. Flush or rinse all products entering the vascular system with sterile isotonic
saline or a similar solution via the guidewire access port prior to use. Consider
saline or a similar solution via the guidewire access port prior to use. Consider
the use of systemic heparinization.
the use of systemic heparinization.
– When the system is introduced into the vascular system, it should be
– When the system is introduced into the vascular system, it should be
manipulated only under high quality fluoroscopy.
manipulated only under high quality fluoroscopy.
– The FoxCross must always be introduced, moved and or withdrawn over a
– The FoxCross must always be introduced, moved and or withdrawn over a
guidewire (0.035").
guidewire (0.035").
– Never attempt to move the guidewire when the balloon is inflated.
– Never attempt to move the guidewire when the balloon is inflated.
– Never use air or any gaseous medium to inflate the balloon.
– Never use air or any gaseous medium to inflate the balloon.
– Do not advance the FoxCross against significant resistance. The cause of
– Do not advance the FoxCross against significant resistance. The cause of
resistance should be determined via fluoroscopy and remedial action taken.
resistance should be determined via fluoroscopy and remedial action taken.
– The minimal acceptable sheath French size is printed on the package label. Do
– The minimal acceptable sheath French size is printed on the package label. Do
not attempt to pass the FoxCross through a smaller sized sheath introducer than
not attempt to pass the FoxCross through a smaller sized sheath introducer than
indicated on the label.
indicated on the label.
– The size of the inflated balloon should be selected not to exceed the diameter of
– The size of the inflated balloon should be selected not to exceed the diameter of
the artery immediately distal, or proximal, to the stenosis.
the artery immediately distal, or proximal, to the stenosis.
– Inflation in excess of the rated burst pressure may cause the balloon to rupture.
– Inflation in excess of the rated burst pressure may cause the balloon to rupture.
Use of a pressure monitoring device is recommended.
Use of a pressure monitoring device is recommended.
V. POTENTIAL COMPLICATIONS
V. POTENTIAL COMPLICATIONS
The following complications may occur as a result of PTA, but may not be
The following complications may occur as a result of PTA, but may not be
limited to:
limited to:
– Spasm reactions of vessel
– Spasm reactions of vessel
– Artery wall injuries of different degrees, including perforation and dissection
– Artery wall injuries of different degrees, including perforation and dissection
– Hemorrhage or hematoma
– Hemorrhage or hematoma
– Arteriovenous fistula, false aneurysm
– Arteriovenous fistula, false aneurysm
– Vascular thrombosis, systemic embolization
– Vascular thrombosis, systemic embolization
– Infection
– Infection
– Pyrogenic reaction
– Pyrogenic reaction
– Amputation
– Amputation
– Death
– Death
Complications related to concomitant medication, e.g.
Complications related to concomitant medication, e.g.
– Drug reactions
– Drug reactions
– Bleeding from anticoagulation/antiplatelet medication
– Bleeding from anticoagulation/antiplatelet medication
– Allergic reactions to contrast medium
– Allergic reactions to contrast medium
VI. SELECTION AND PREPARATION OF DEVICE AND
VI. SELECTION AND PREPARATION OF DEVICE AND
COMPATIBILITY WITH ACCESSORIES
COMPATIBILITY WITH ACCESSORIES
Selection of balloon size and compatibility of system to accessories
Selection of balloon size and compatibility of system to accessories
The diameter of the expanded balloon should not exceed that of the artery just
The diameter of the expanded balloon should not exceed that of the artery just
distal, or proximal, to the stenosis.
distal, or proximal, to the stenosis.
Verify that the selected accessories accommodate the balloon catheter as labeled.
Verify that the selected accessories accommodate the balloon catheter as labeled.
Preparation of PTA catheter
Preparation of PTA catheter
It is very important to check before use that the packaging has not been damaged in
It is very important to check before use that the packaging has not been damaged in
a way that might have rendered the catheter unsterile. It is also important at the
a way that might have rendered the catheter unsterile. It is also important at the
same time to verify that the chosen catheter is the correct one for the planned
same time to verify that the chosen catheter is the correct one for the planned
procedure.
procedure.
To verify the integrity of the PTA catheter, inflate and deflate the balloon and make
To verify the integrity of the PTA catheter, inflate and deflate the balloon and make
sure that all the air is eliminated, and there is no leakage through any of the
sure that all the air is eliminated, and there is no leakage through any of the
different connections. The following steps should be taken:
different connections. The following steps should be taken:
1) Fill a syringe with a mixture of contrast medium and normal saline.
1) Fill a syringe with a mixture of contrast medium and normal saline.
2) Attach the syringe to the connector of the balloon lumen. Hold the catheter with
2) Attach the syringe to the connector of the balloon lumen. Hold the catheter with
the distal tip pointing downwards.
the distal tip pointing downwards.
3) Remove the protective tubing from the balloon.
3) Remove the protective tubing from the balloon.
4) Inject enough inflation medium to partially inflate the balloon.
4) Inject enough inflation medium to partially inflate the balloon.
5) Deflate the balloon by drawing back on the syringe plunger, thereby drawing the
5) Deflate the balloon by drawing back on the syringe plunger, thereby drawing the
air bubbles from the balloon into the syringe.
air bubbles from the balloon into the syringe.
6) Repeat steps 4 and 5 until all of the air in the balloon has been displaced by the
6) Repeat steps 4 and 5 until all of the air in the balloon has been displaced by the
inflation medium.
inflation medium.
7) Aspirate firmly to remove all inflation medium and refold the balloon. Leave the
7) Aspirate firmly to remove all inflation medium and refold the balloon. Leave the
negative pressure until the FoxCross is ready for use.
negative pressure until the FoxCross is ready for use.
8) Slide the protective tubing back over the balloon to achieve the smallest profile
8) Slide the protective tubing back over the balloon to achieve the smallest profile
prior to introduction into vascular system.
prior to introduction into vascular system.
VII. INTRODUCTION AND DILATATION
VII. INTRODUCTION AND DILATATION
Introduction of the system
Introduction of the system
1) The PTA catheter is designed to be introduced percutaneously using the
1) The PTA catheter is designed to be introduced percutaneously using the
Seldinger technique.
Seldinger technique.
2) When the catheter is ready for introducing into the vascular system, the balloon
2) When the catheter is ready for introducing into the vascular system, the balloon
protection tubing should be removed completely from the catheter.
protection tubing should be removed completely from the catheter.
3) Place the prepared catheter over a pre-positioned guidewire and advance the tip
3) Place the prepared catheter over a pre-positioned guidewire and advance the tip
to the introduction site. It is advantageous to use the balloon catheter with an
to the introduction site. It is advantageous to use the balloon catheter with an
introducer to facilitate entry.
introducer to facilitate entry.
Note: Perform all further catheter manipulations under fluoroscopy.
Note: Perform all further catheter manipulations under fluoroscopy.
4) Position the catheter with the center of the balloon in the middle of the stenosis.
4) Position the catheter with the center of the balloon in the middle of the stenosis.
The radiopaque marker bands indicate the length of the balloon.
The radiopaque marker bands indicate the length of the balloon.
Dilatation of the balloon
Dilatation of the balloon
5) When an acceptable position has been reached, inflate the balloon to achieve
5) When an acceptable position has been reached, inflate the balloon to achieve
the desired dilatation. Caution: Do not exceed the rated burst pressure. Higher
the desired dilatation. Caution: Do not exceed the rated burst pressure. Higher
pressure can damage the balloon or catheter or overdistend the selected artery.
pressure can damage the balloon or catheter or overdistend the selected artery.
6) Deflate the balloon by aspirating the inflation syringe or inflation device.
6) Deflate the balloon by aspirating the inflation syringe or inflation device.
7) Maintaining a vacuum in the balloon, withdraw the catheter. Note: Gentle
7) Maintaining a vacuum in the balloon, withdraw the catheter. Note: Gentle
counterclockwise twisting motion of the balloon may ease withdrawal through the
counterclockwise twisting motion of the balloon may ease withdrawal through the
sheath or from the percutaneous entry site. If the balloon cannot be withdrawn
sheath or from the percutaneous entry site. If the balloon cannot be withdrawn
through the sheath, withdraw the catheter and sheath as one unit.
through the sheath, withdraw the catheter and sheath as one unit.
8) Please note that if multiple balloon-inflations and -deflations have taken place,
8) Please note that if multiple balloon-inflations and -deflations have taken place,
some resistance can occur upon device withdrawal.
some resistance can occur upon device withdrawal.
9) The results should be checked by angiography.
9) The results should be checked by angiography.
VIII. PRODUCT INFORMATION DISCLOSURE
VIII. PRODUCT INFORMATION DISCLOSURE
Abbott Vascular has exercised reasonable care in the manufacture of this device.
Abbott Vascular has exercised reasonable care in the manufacture of this device.
Abbott Vascular excludes all warranties, whether express or implied by operation of
Abbott Vascular excludes all warranties, whether express or implied by operation of
law or otherwise, including, but not limited to, any implied warranties of
law or otherwise, including, but not limited to, any implied warranties of
merchantability or fitness, since handling and storage of this device as well as
merchantability or fitness, since handling and storage of this device as well as
factors relating to the patient, the diagnosis, treatment, surgical procedures, and
factors relating to the patient, the diagnosis, treatment, surgical procedures, and
other matters beyond Abbott Vascular's control directly affect this device and the
other matters beyond Abbott Vascular's control directly affect this device and the
results obtained from its use. Abbott Vascular shall not be liable for any incidental
results obtained from its use. Abbott Vascular shall not be liable for any incidental
or consequential loss, damage, or expense, directly or indirectly arising from the
or consequential loss, damage, or expense, directly or indirectly arising from the
use of this device. Abbott Vascular neither assumes, nor authorizes any other
use of this device. Abbott Vascular neither assumes, nor authorizes any other
person to assume for it, any other or additional liability or responsibility in
person to assume for it, any other or additional liability or responsibility in
connection with this device.
connection with this device.
Caution, consult accompanying documents
Caution, consult accompanying documents
Contents
Contents
Nominal Balloon Diameter
Nominal Balloon Diameter
Nominal Balloon length
Nominal Balloon length
Rated Burst Pressure
Rated Burst Pressure
Nominal Pressure
Nominal Pressure
Do not exceed!
Do not exceed!
Usable Length
Usable Length
Recommended Introducer
Recommended Introducer
Recommended Guide Wire
Recommended Guide Wire
Only sterile and non pyrogenic in unopened packages
Only sterile and non pyrogenic in unopened packages
Do not use if package is damaged
Do not use if package is damaged
Temperature limitation
Temperature limitation
Keep away from sunlight
Keep away from sunlight
Keep dry
Keep dry
Manufactured by
Manufactured by
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