Instructions For Use - IHT Cordynamic Hunter Bedienungsanweisung

UK FAST EXCHANGE INFUSION, INJURY MEASURING AND THROMBUS EXTRACTION

INSTRUCTIONS FOR USE:

Sterilised with ethylene oxide gas. Pyrogen-free. Single use. Do not re-sterilise or re-process. Inspect package integrity. Use before the
expiry date. Store in a dry, cool place, protected from light.
1. Description
The soft thrombus extraction catheter is a fast exchange type catheter, with a hole and radiopaque markers close to the distal tip. The body of the
catheter has a combination of simple lumen in its proximal part and double lumen in its distal part. The larger lumen is used to inject fluids (medicines
or contrast liquid) or to extract the thrombus when connected to the syringe included in the system, whereas the other lumen allows the use of the
guide in order to facilitate catheter penetration towards and through the stenosis to be treated.
In the distal part, there is a series of radiopaque markers close to the tip at distances of 0, 10, 20, and 30 mm in order to measure in situ the length
of the lesion to be treated. Moreover, there is another radiopaque marking on the insertion port of the wire guide delimiting the proximal part from
the distal part. On the most distal part, there is a hole used to inject contrast liquid or medication to arrange microcirculation before recannulating the
artery, or, if visualising the thrombus, to extract it "in situ" by connecting the device to the manual extraction syringe included. The catheter ends in a
conic tip with a small diameter in order to penetrate complete occlusions formed by recent acute myocardial infarction. At the distal part, the catheter
is coated with a lubricious hydrophilic coating.
The proximal body has an outer diameter of 1.40 mm and a Standard luer adaptor on its proximal part to be connected to the extension line and the
thrombus extraction syringe. The entire system is compatible with 6F guide catheters.
Two extraction syringes, a one-way valve, an extension line with attached stopcock and a cup to collect and deposit the clots extracted from the patient
are provided with the catheter.
2. Indications
The Cordynamic® Hunter thrombus extraction catheter is especially suitable for:
- Visualising the state of the artery and the possible existence of thrombi beyond acute total occlusion.
- Administering medicinal products to prepare microcirculation.
- Measuring the lesion "in situ" thanks to its radiopaque markers.
- Extracting emboli and soft thrombi recently formed in the coronary arterial system.
3. Contraindications
• Blood vessels < 2 mm in diameter
• Spasm of a coronary artery without significant stenosis
• Extraction of adhered or calcified fibrous material such as chronic clots or atherosclerotic plates
• Venous system
4. Warnings
• Single-use device. DO NOT re-sterilise. Respect the expiry date on the package.
• Do not use organic solvents or oil-based products (such as contrast mediums Ethiodol or Lipiodol) or highly viscous products.
• Once within the vascular system, catheter handling must be performed under high quality fluoroscopic vision. In the event of any resistance, inject
the contrast medium through the catheter and determine the cause before continuing with the procedure.
• Once thrombi extraction has been started via the extraction lumen it is not possible to use the catheter to administer medicinal products or to inject
a contrast medium, since possible thrombi remaining inside the catheter could be re-released into the vasculature, possibly causing thromboembolic
events, serious lesions or even death. If necessary, extract the catheter, clean it outside the patient and introduce it once again.
• If the flow inside the syringe stops or becomes restricted during thrombus extraction, do not try to irrigate the extraction lumen inside the patient.
Extract the catheter from the patient, irrigate the extraction lumen by cleaning it carefully and reintroduce it inside the patient if necessary.
• The PTCA must be performed only in hospitals equipped with emergency measures to perform open heart surgery in the event of complications.
The procedures must be performed by physicians with suitable training in the use of the device.
• Assess the patient's critical condition
• Verify the accuracy of the data
5. Precautions
Prior to use inspect the packaging and remove any products whose packaging is in bad condition.
Inspect the catheter for any bends or kinks, and do not use a catheter which are not in good conditions
Percutaneous catheters must only be used by highly trained physicians who are familiar with percutaneous transluminal coronary angioplasty techniques.
The administration of anticoagulants and coronary vasodilating agents is recommended before introduction of the catheter.
When using a 6F guide catheter, there will be insufficient room to deliver contrast around the Hunter catheter.
Check that all fittings are secure so that air is not introduced into the extension line or syringe during extraction.
6. Adverse effects.
The following adverse effects may occur:
• Death
• Acute myocardial infarction
• Unstable angina
• Embolism
• Perforation and rupture of blood vessels
• Coronary artery spasms
• Arrhythmias
• Total occlusion of the coronary area
• Haematomas
• Haemorrhages
• Infections.
• Arteriovenous fistula.
• Changes in blood pressure
• Sensitivity or allergic reactions to the contrast medium, medicinal products and materials
CATHETER FOR PCI
®
Cordynamic Hunter