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Intructions For Use
Carefully read all instructions prior to use.
Observe all contraindications, warnings
and precautions noted in these directions.
Failure to do so may result in patient
complications. Merit Medical Systems,
Inc. relies on the physician to determine,
assess, and communicate to each patient
all foreseeable risks of the procedure.
For U.S.-California Only.
Proposition 65, a State of California voter initiative, requires
the following notice:
WARNING: This product and its packaging have been
sterilized with ethylene oxide. This packaging may expose
you to ethylene oxide, a chemical known to the state
of California to cause cancer or birth defects or other
reproductive harm.
CAUTION:
•
Federal (USA) law restricts this device to sale by or on
the order of a physician. This device should be used
only by physicians thoroughly trained in percutaneous
procedures.
•
Do not alter this device in anyway.
•
This device is supplied sterile and intended for
one-time use only. Do not use any unit if its package is
opened or damaged. Do not resterilize and/or reuse.
HOW SUPPLIED:
Sterile: Sterilized with ethylene oxide gas. Non-pyrogenic.
Contents: One (1) Radiopaque Sheath, one (1) Radiopaque
Dilator, one (1) 0.035" x 135cm Guidewire
NOTE: Sheath Length, Diameter, and Curve configurations
are indicated on the product label.
DESCRIPTION:
The Braided Transseptal Sheath is designed to provide a
conduit to deliver diagnostic and therapeutic catheters to
specific heart chambers and locations. It provides support
for positioning and maintaining the position of catheters at
specific locations in the heart. The sheath may be used for
percutaneous entry.
The kit consists of three components: a sheath, a dilator,
and a J-tipped guidewire.
The sheath has a radiopaque marker band which aids in
defining the location of the tip, an atraumatic soft tip, and a
lubricious coating on the inner and outer surface.
The dilator is designed to conform to the inner diameter
and curve of the sheath, and has a tapered tip.
To facilitate access to a variety of cardiac structures and
sites, the sheaths are available in various sizes, lengths and
tip curve configurations.
INDICATIONS:
For the percutaneous introduction of various types of
cardiovascular catheters to all heart chambers, including
the left atrium via transseptal puncture.
STORAGE:
Store in a cool, dark, dry place.
WARNINGS:
1. Contents supplied STERILE using an ethylene oxide
(EO) process. Do not use if sterile barrier is damaged.
2. For single use only. Do not reuse, reprocess or
2
resterilize. Reuse, reprocessing or resterilization may
compromise the structural integrity of the device and/
or lead to device failure which in turn may result in
patient injury, illness or death.
This single-use product is not designed or validated
to be reused. Reuse may cause a risk of cross-
contamination, affect the measurement accuracy,
system performance, or cause a malfunction as a
result of the product being physically damaged due to
cleaning, disinfection, re-sterilization, or reuse.
3. The device(s) should be used by physicians engaged
in the practice of specialized invasive cardiology
techniques. Use of the device should be restricted to
those physicians specifically trained in the approach
to be used.
4. When the sheath is left in the vessel, a continuous
heparinized infusion under pressure is strongly
recommended through the sheath sideport.
5. Infusion through the sideport should only be done
after all air is removed from the unit.
6. Dilators and catheters should be removed slowly from
the sheath. Rapid removal may damage the valve
components resulting in blood flow through the valve,
as well as cause a vacuum which may allow air to
enter the sheath.
7. Aspiration of the side port is recommended when
withdrawing the catheter, probe, or dilator to remove
any fibrin deposition which may have accumulated in
or on the tip of the sheath.
8. Careful sheath manipulation must be performed in
the presence of an implantable cardiac device of any
kind to minimize the potential to displace or dislodge
lead placement.
9. Direct percutaneous insertion of the sheath requires
the use of the dilator to minimize the potential risk of
vessel injury due to a flared tip.
10. Fluoroscopic monitoring of the location of the distal tip
of the sheath using the radiopaque marker, especially
when used in a transseptal approach, is recommended.
PRECAUTIONS:
1. Aspiration and flushing of the sheath, dilator, and
catheter should be performed frequently to help
minimize the potential for air embolism.
2. Indwelling sheaths should be internally supported by a
catheter, electrode, or dilator.
3. Never advance, torque, or withdraw guidewire or
sheath when resistance is met. Determine cause by
fluoroscopy and take remedial action.
4. Use the sideport for injection or aspiration of sheath
and sideport assembly. Assure that stopcock is
in the closed position after flushing, to prevent
back-bleeding.
5. The following conditions require that special care
be taken when using this product involving the
transseptal approach.
• enlarged aortic root
• marked right atrial enlargement
• small left atrium
• marked distortion of the thoracic configuration (e.g.
kyphosis or scoliosis)
6. Care should be taken to avoid excessive bending of the
sheath and/or dilator before and during use.
7. Fluoroscopic procedures involve exposure to ionizing
radiation by the patient and staff. Precautions to
minimize exposure should be taken and protective
equipment should be used.
8. Fluoroscopic guidance should be used when advancing
the Braided Transseptal Sheath and/or dilator. When
advancing the sheath and/or dilator across a valve, a
guidewire or pigtail should be used.
9. The sheath, dilator, and guidewire are designed for
single use only. Reuse may expose the patient to
communicable disease and/or injury.
10. Arrhythmias may occur during the use of any
intracardiac device. Careful monitoring and availability
of emergency equipment are mandatory.
11. When using the Braided Transseptal Sheath in the
presence of radio frequency ablation, care must be
taken to assure all ablating elements are outside
the sheath.
ADVERSE REACTIONS:
Adverse reactions to cannulation of the peripheral
vasculature and intracardiac placement of the sheath and
dilator may include, but are not limited to:
•
infection
•
local nerve damage
•
perforation
•
dissection
•
AV fistula formation
•
pseudoaneurysm formation
•
arrhythmias
•
hematoma
•
hemorrhage
•
thromboembolic events
•
catheter entrapment
•
valve damage
•
pacemaker/defibrillator lead displacement
•
air embolus
•
vasovagal reaction
•
vessel trauma
•
vessel spasm
•
atrial septal defect
•
aortic puncture
•
perforation and/or tamponade
•
coronary artery spasm and/or damage
•
stroke
•
myocardial infarction
•
pericardial/pleural effusion
•
pulmonary edema
REQUIRED EQUIPMENT:
Carefully read the instructions for each accessory before use.
Needle
Heparinized Normal Saline
INSPECTION PRIOR TO USE:
Carefully inspect the package for any breach of the sterile
barrier or damage to the contents prior to use.
USE STERILE TECHNIQUE:
Suggested Procedure
1. Open package and place contents on sterile field.
2. Prep skin and drape in area of anticipated vein-
puncture as desired.
3. Perform skin wheal using 25 gauge needle (not
supplied).
4. Locate vessel using small gauge needle and syringe.
5. Insert Introducer Needle (not supplied) into vessel.
Look for blood return to confirm proper needle
position.
6. Insert soft tip of guidewire through Introducer Needle
into vessel. Advance guidewire to required depth. At no
time should the guidewire be advanced or withdrawn
when resistance is met. Determine the cause of
resistance before proceeding.
7. Hold guidewire in place and remove Introducer Needle.
Do not withdraw the guidewire back into the cannula
as this may result in separation of the guidewire. The
cannula should be removed first.
8. Enlarge cutaneous puncture site with scalpel.
9. Assemble dilator and sheath together until the dilator
hub locks into the sheath hub.
10. Thread the dilator/sheath assembly over the
guidewire, using a slight twisting motion.
11. The Braided Transseptal Sheath may now be positioned
to deliver catheters to desired locations.
12. Aspirate all air from the sheath valve assembly by
using a syringe connected to the sideport. Flush the
sheath through the sideport. If transseptal puncture is
required, continue with steps below.
Suggested Procedure
1. Advance the Braided Transseptal Sheath and Dilator
assembly into the superior vena cava (SVC) just above
the right atrium.
2. Separate the dilator and sheath hub approximately
1cm while slowly advancing the sheath over the
dilator. This will aid the introduction of the curved
transseptal needle (not supplied).
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