Guerbet Sequre, Инструкция по эксплуатации

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ENGLISH - Instructions for use
Read all instructions prior to use. To avoid complications, observe all warnings and precautions throughout these instructions. Caution: US
Federal Law restricts this device to sale by or on the order of a physician. In accordance with European Regulation (EU) 2017/745 on medical
devices, In the event of any serious incident occurring in relation to this medical device, report the details to the manufacturer and the competent
authority of the European Member State in which the user is established.
Product Description
The S equrE® microcatheters are single use microcatheters primarily comprised of a luer lock hub, a strain relief cover and tube, central shaft, and
distal tip with a radiopaque marker for visualization. The SequrE® microcatheters are used for infusion of therapeutic agents, embolic material
and fluid such as contrast media.
The catheters consist of a metal braid reinforced shaft with external multi-polymer tubing. The braid provides trackability, pushability and torque
transmission to the microcatheter as well as visibility under fluoroscopy. The inner lumen is made of PTFE (polytetrafluoroethylene), which
allows for the smooth passage of fluids, embolic agents and devices such as guide wires. The distal section of the shaft is coated in a hydrophilic
polymer layer, which ensures high lubricity when wet with saline or blood.
At the proximal end there is a luer-compatible hub connected to a strain relief cover which helps prevent kinking due to the weight of the hub.
The SequrE®’s distal end has two radiopaque markers that contribute to the fluoroscopic visualization of the distal tip of the microcatheter. The
two radiopaque bands mark the boundaries of the SequrE® side holes/slits.
The SequrE® microcatheters are single lumen devices and are available in several different diameters and lengths..
Table 2: SequrE
®
Microcatheter Specifications
Attribute Specification
Microcatheter OD
(Proximal/Distal)
2.9/2.4 Fr
(0.97/0.8 mm)
2.9/2.7 Fr
(0.97/0.9 mm)
3.0/2.8 Fr
(1.00/0.93 mm)
Catheter Inner Diameter
0.022”
(0.56 mm)
0.025”
(0.64 mm)
0.027”
(0.69 mm)
Functional Length
105
cm
130
cm
150
cm
105
cm
130
cm
150
cm
105
cm
130
cm
150
cm
Maximal Compatible
Guidewire OD
0.018”
(0.46 mm)
0.021”
(0.53 mm)
0.021”
(0.53 mm)
Recommended
Guiding Catheter
Min. 0.038”
(0.97 mm) guidewire compatible
Compatible Embolic Microspheres OD 70-500 µm 70-500 µm 70-700 µm
Compatible Embolic Coil Size 0.018” 0.018” 0.018”
Indications For Use
The S equrE® microcatheters are intended for the infusion of contrast media into all peripheral vessels. The SequrE® microcatheters are also
intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The SequrE® microcatheters should not be used in cerebral
vessels.
Contraindications
Generally, angiography or intravascular therapy is contraindicated for, but not limited to, the patients listed below:
• Patients in the acute phase of myocardial infarction
• Patients with serious arrhythmia
• Patients with serious serum electrolyte imbalance
• Patients who in prior procedures have developed an adverse reaction to
the injection of contrast media
• Patients with renal dysfunction
• Patients with coagulopathy or those whose blood has suffered a serious
change in coagulation capability for some reasons
• Patients who cannot lie on their back on the operating table because of
congestive heart failure or some respiratory disorder
• Patients with mental disease or those who are not expected to lie quietly
during angiography
• Patients who are or may be pregnant
• Any other patients who are judged unsuitable for the procedure by the
physician.
• Do not use in patients for whom anticoagulant and antiplatelet therapy
is contraindicated.
Complications
Angiography or intravascular therapy may be accompanied by, but not limited to, the following:
• Headache
• Nausea and vomiting
• Fever and chill
• Abnormality in blood sampling tests
• Blood pressure drifting
• Shock
• Myocardial infarction
• Renal failure
• Infection and pain at the puncture site
• Inflammation with embolic material
• Cerebral edema
• Bradycardia
• Cerebral infarction from peripheral artery
occlusion
• Hemorrhage, hematoma, arterio-venous
fistula and/or false aneurysm at puncture site
• Spasm, artery perforation, aortic dissection
and/or false aneurysm with the use of a guide
wire or catheter
• Behavior disorder
• Death