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QXMedical is not responsible for mis-sizing, misuse or
misplacement of the device.
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Lead Extraction should be performed at institutions
with cardiothoracic surgical capabilities by physicians
knowledgeable in the techniques and devices for lead or
catheter removal. Complication prevention and management
protocols should be in place and routinely practiced. It is
strongly suggested that the recommendations for lead
management of the Heart Rhythm Society (HRS) and European
Heart Rhythm Association (EHRA) be followed for best results.
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Prior to initiating a Lead Extraction procedure, a guidewire
should be placed through a venous access site and across the
length of the SVC. Attempting to place a guidewire after a
venous tear occurs may:
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Result in an inability to traverse the SVC with the guidewire
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Result in the guidewire exiting the vasculature at the tear
site
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Result in an inability to place the Occlusion Balloon
Catheter
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Delay or prevent the ability to achieve occlusion
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Do not position the Occlusion Balloon Catheter in a manner
that would obstruct the right atrium. Obstruction of the atrium
could lead to arrhythmias and/or hemodynamic compromise.
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Occlusion of the SVC beyond 30 minutes is not recommended
as this may increase the risk of adverse physiologic or
neurologic complications.
5. PRECAUTIONS
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Preparations should be made and a trained vascular
surgical team available in the event conversion to open
surgery is required.
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Carefully inspect the package and catheter prior to use to
verify no damage occurred during shipment. Do not use if the
package or catheter is damaged since the sterility or integrity
of the device may be compromised and thus increasing the risk
of patient infection and device malfunction.
Use the catheter prior to the Use By date specified on the
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package.
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Do not attempt to pass the catheter through a smaller than
recommended introducer sheath. Damage to the device may
occur.
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0.035" diameter stiff or super-stiff guidewires are
recommended.
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To avoid damage to the catheter or vessel, do not advance or
withdraw the device without a guidewire in place.
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Catheter should not be advanced into a vessel having a
diameter smaller than the catheter outer diameter. Damage to
the device or vessel may occur.
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Carefully monitor the patient's blood pressure and other vital
signs throughout the procedure.
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If an obstruction in the vessel (e.g., a tortuous bend, stenosis,
calcification, etc.) prevents advancement of the catheter, use
standard techniques to try to dilate and/or straighten the
vessel before continuing to advance the catheter.
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It is recommended that back-up Occlusion Balloon Catheters
are made available.
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Balloon is highly compliant. Inflate slowly. Do not over-inflate
in vessels. Operator should visualize the balloon at all times
during inflation to detect any movement. Use special care in
areas of diseased vessels to avoid rupture or vessel trauma.
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The Occlusion Balloon Catheter is not intended for use as an
angioplasty or dilatation balloon.
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The Occlusion Balloon Catheter is not intended for use as an
infusion catheter.
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When aligning the position of the catheter so that the balloon
is in proper position for expansion within vessel, pay careful
attention to the fluoroscope location in order to avoid parallax
or other sources of visualization error.
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Do not use the Occlusion Balloon Catheter for more than 20
inflation/deflation cycles.
QXMédical, LLC
Document Part Number: 3116-001, Rev 01 (05/2019)
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Do not exceed 32mm balloon diameter and do not exceed
60cc inflation volume at 32mm balloon diameter. Adhere to
the balloon inflation guidelines outlined in Table 1.
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To avoid balloon damage or rupture, lead extraction tools
(such as extraction sheaths) should be removed from the SVC
area prior to placing the Occlusion Balloon Catheter.
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If surgical repair of a venous tear requires suturing, use caution
to avoid puncturing the balloon.
6. POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
Complications may occur with the use of any occlusion balloon
catheter or during any catheterization procedure. Therefore,
only physicians trained in electrophysiology, vascular surgery,
interventional radiology or cardiology, and who have completed
training or have experience with balloon catheters and associated
devices should consider using this device. Possible complications
associated with this type of procedure include but are not limited
to the following:
CLINICALLY RELATED:
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Allergic reaction
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Hemodynamic deterioration
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Thromboembolic episode
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Sepsis/infection
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Vessel perforation, dissection, rupture or injury
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Occlusion at some locations may cause arrhythmia
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Paresthesia
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Drug reactions
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Entry site infection
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Entry site hematoma
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Cardiac events
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Respiratory failure
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General malaise
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Arterial thrombosis and/or embolism
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Hemorrhage
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Stroke
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Aneurysm rupture
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Renal complications
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Death
DEVICE RELATED:
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Balloon rupture
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Inability to inflate/deflate balloon
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Inability to insert guidewire
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Inability to withdraw catheter from introducer
7. PACKAGING, STERILIZATION AND STORAGE
The device has been sterilized using ethylene oxide (EO) and is
supplied sterile and non-pyrogenic. The package label indicates
the Use By date.
Do not use the device after the Use By date. The device sterility
and integrity may be compromised and possibly result in patient
infection and device malfunction.
The device should be stored in cool dry place.
8. RECOMMENDED ITEMS
Each Occlusion Balloon Catheter package includes the following:
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Single-use sterile disposable catheter with extension tube and
stopcock mounted on a paperboard card.
Materials required but not provided are:
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Compatible Introducer Sheaths with hemostasis valve
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Guidewires, 0.035" diameter, Stiff or Super Stiff
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