How Supplied; Warnings And Precautions - Medtronic Symplicity Spyral Handbuch

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The Symplicity Spyral™ catheter is intended for use only with the Symplicity G3™ generator.
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The Symplicity Spyral™ catheter has a limited shelf life. The product must be used on or before the Use By date provided on the label.
■ Prior to use, the product should be stored in a cool, dry place. The product should not be exposed to organic solvents, ionizing radiation, or ultraviolet light. Carefully inspect the
sterile package for damage before opening. Do not use if the package has been damaged or opened.

5. How Supplied

■ The Symplicity Spyral™ catheter is contained in a lidded tray that is sealed within a sterile, single pouch and supplied in a labeled product carton.
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The Symplicity G3™ generator and the optional foot switch and cart are nonsterile and reusable. These items are supplied separately from the Symplicity Spyral™ catheter.
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Items that are not supplied but are required to complete the treatment include a 0.36 mm (0.014 in) guidewire (preferably non hydrophilic coated) and a standard adult-size dispersive
electrode. In addition, the following accessories are needed to gain access to the target vessels under fluoroscopy: a 6 Fr guide catheter 45 to 90 cm, an introducer sheath, a stopcock
sidearm, and a Tuohy-Borst adapter.
6. Risks
Intervention Risks: Death, cardiopulmonary arrest, heart rhythm disturbances including bradycardia, formation of blood clots and/or embolism (which may result in ischemic events
such as myocardial infarction, pulmonary embolism, stroke, kidney damage, or peripheral ischemia), retroperitoneal hematoma, hematoma, bruising, bleeding, arterial damage, arterial
spasm, arterial stenosis, arterial dissection or perforation, renal artery aneurysm, kidney perforation, pseudoaneurysm, AV fistula, pain, skin burns, and thermal injury to the vasculature
or other structures from energy application.
Contrast agents, narcotics, anxiolytics, other pain medications and anti-vasospasm agents are also commonly utilized during the procedure or after the procedure; use of these agents
is associated with known risks.
Other Treatment Risks: Proteinuria, hematuria, electrolyte disturbances, worsening renal function, hypotension, hypertension, orthostatic hypotension, hypotension causing end organ
hypoperfusion, nausea, and vomiting.
Biological Hazards: Risks of infection, toxicity, abnormal hematology profile, allergy, hemorrhage, and pyrogenicity.
Environmental Hazards: Consistent with standard hospital protocols for proper use and disposal of biological wastes.
Radiation Hazards: Consistent with normal use of x-ray during interventional procedures.

7. Warnings and Precautions

7.1. Related to the Use of Radiofrequency in Catheterization Laboratories
■ Radio frequency surgery uses high-frequency output. Do not perform procedures if flammable or explosive media are present, such as flammable anesthetics or skin preparation
agents.
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Interference produced by the operation of high-frequency surgical equipment may adversely influence the operation of other electronic medical equipment such as monitors and
imaging systems.
■ Hazardous electrical output. This equipment is for use only by qualified medical personnel trained in the use of this equipment.
7.2. Related to Interventional Techniques
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A thorough understanding of the technical principles, clinical applications, and risks associated with percutaneous transluminal catheterization in renal arteries is necessary before
using this device.
■ Ensure that the guide catheter is flushed with heparinized saline between each treatment.
■ Do not flush the catheter while in the hoop, nor flush the catheter lumen prior to use. It is also not recommended to wipe the catheter with a wet gauze prior to use.
■ During fluoroscopy, be careful to avoid excessive exposure of the patient to contrast agents.
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Avoid using ionized contrast agent when performing renal denervation.
7.3. Related to Patient
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The Symplicity Spyral™ catheter has not been evaluated in patients who are pregnant, nursing, or planning to become pregnant.
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The Symplicity Spyral™ catheter has not been evaluated in patients with Type I diabetes mellitus.
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The Symplicity Spyral™ catheter has not been evaluated in patients with prior renal angioplasty, indwelling renal stents, or aortic grafts.
■ The Symplicity Spyral™ catheter has not been tested in abnormal renal anatomy (eg, dual renal arteries).
■ Avoid use of the Symplicity Spyral™ catheter in individuals in whom a reduction in blood pressure would be considered hazardous, eg, those with hemodynamically significant
valvular heart disease.
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Implantable pacemakers and implantable cardioverter/defibrillators (ICDs) may be adversely affected by RF ablation. Consider deactivating ICDs during ablation, having temporary
external sources of pacing and defibrillation available during ablation, and performing a complete analysis of the implanted device function after ablation.
■ Avoid treating in arteries with a diameter less than 3 mm or greater than 8 mm.
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Avoid treating in arteries with significant disease or with flow-limiting obstructions.
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Safe use of monopolar radio frequency surgery demands proper coupling of the dispersive electrode to the patient. Follow all of the manufacturer's directions for the placement of
the dispersive electrode and for proper insulation between the patient and any metal surfaces.
■ Failure to achieve good skin contact by the entire adhesive surface of the dispersive electrode may result in a burn or high impedance measurements.
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The patient should not come into contact with metal parts which are grounded or have an appreciable capacitance to ground (eg, operating table supports, etc.). The use of antistatic
sheeting is recommended for this purpose.
■ Heart rate may drop during the ablation procedure. Administration of medication such as atropine might be needed.
■ Patient is likely to experience pain when radiofrequency energy is delivered. Proper pain medication should be administered at least 5 minutes prior to ablating renal nerves.
■ Nitroglycerine should be administered to prevent vessel spasm during ablation.
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An activated clotting time (ACT) of at least 250 seconds should be maintained during the procedure; proper use of systemic anticoagulation medication is required.
7.4. Related to Ablation Catheter and Generator
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The Symplicity G3™ generator should be powered on and allowed to complete system self-test prior to placing the Symplicity Spyral™ catheter within the vasculature.
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While in use, position the Symplicity G3™ generator more than 31 cm (12 in) away from a wall, and do not cover the generator.
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The Symplicity Spyral™ catheter is intended for single patient use only. Do not resterilize or reuse. Reuse, reprocessing or resterilization may compromise device integrity and
functionality and may create the risk of transmission of infectious diseases from one patient to another, which may result in injury, illness or death of the patient.
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Do not advance the Symplicity Spyral™ catheter against resistance.
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Avoid advancing guidewire too distal to reduce risk of damaging kidney. Similarly, it is recommended to not use hydrophilic guidewires to prevent unintentional damage to kidneys
or renal arteries.
■ The Symplicity Spyral™ catheter should be deployed while using fluoroscopy.
■ Avoid making major adjustments to the Symplicity Spyral™ catheter while the distal tip is deployed, such as dragging the catheter or torquing it beyond 180 degrees.
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Avoid placing an electrode at the ostium of small branch arteries, such as those perfusing the adrenal glands.
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Avoid treating renal artery segments distal to the significant renal artery branch point(s) and segments that may be in close proximity to structures such as the ureter or kidney.
7.5. Related to RF Treatment
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Remove any guidewires that are not contained within the Symplicity Spyral™ catheter from the treatment site before activating the RF output.
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Avoid overlapping previous ablation sites.
■ Avoid ablating if the distance between the distal and proximal electrodes is less than 5 mm.
■ Do not ablate if electrodes are in contact with each other per fluoroscopic observation.
4 Instructions for Use English
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2013/JUL/16 at 10:32 a.m. Doc number: M333565F001 Rev. 1A [28L(03)]
Printspec j - 8.5 x 11.0 inches