Drakon ™ Peripheral Microcatheter

High performance peripheral microcatheter for challenging anatomies

Optimized pushability and torqueability - 16 yarns of tungsten braid provides support, increased pushability and best-in-class torqueability.
Smooth delivery - Inner PTFE lumen facilitates smooth passage of fluids, embolic agents, and devices (such as guidewires
Enhanced & total visibility - Tungsten RO braid runs through the entire catheter length, allowing enhanced visbility under fluoroscopy; Distal RO marker enhances tip visibility.
Gradual flexibility - Multiple segments of high-performance polymers designed to enhance proximal support & pushability while providing optimal flexibility & trackability to the distal tip.
Easy navigation through tortuous vessels - Made possible by hydrophilic coating

Compatibilities (1200 PSI Max Injection Pressure)

ATTRIBUTE	SPECIFICATION
Microcatheter OD (Proximal/Distal)	2.9 / 2.4 Fr (0.97 / 0.80 mm)			2.9 / 2.7 Fr (0.97 / 0.90 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
Dead Space Volume	0.48 ml	0.54 ml	0.59 ml	0.56 ml	0.64 ml	0.7 ml	0.62 ml	0.71 ml	0.78 ml
Flow rate with lodinated Contrast Media (300 mg/ ml, 37° C)	2.1 ml/sec	1.7 ml/sec	1.5 ml/sec	3.1 ml/sec	2.6 ml/sec	2.4 ml/sec	3.9 ml/sec	3.4 ml/sec	3.1 ml/sec
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
Maximal Compatible Embolic Microspheres	500 μm			700 μm			700 μm*
Compatible Embolic Coil Size	0.018"			0.018"			0.018"

^{Drakon™ is compatible with Lipiodol (Ethiodized Oil) Injection, dimethyl sulfoxide (DMSO), NBCA glue and Ethanol 4}
^{*For microspheres above 700 µm, refer to manufacturers’ instructions for use for microcatheters’ size compatibilities.}

Specification & Ordering Information

PRODUCT REFERENCE	ORDER NUMBER	CATHETER OD (F / MM)	FUNCTIONAL LENGTH (CM)	INNER DIAMETER (IN / MM)	RECOMMENDED GUIDEWIRE (IN / MM)	SHAPE
DK24_105	232877	2.4 F (0.80 mm)	105	0.022” (0.56 mm)	0.018” (0.46 mm)	Straight
DK24_130	234050	2.4 F (0.80 mm)	130	0.022” (0.56 mm)	0.018” (0.46 mm)	Straight
DK24_150	234051	2.4 F (0.80 mm)	150	0.022” (0.56 mm)	0.018” (0.46 mm)	Straight
DK27_105	232884	2.7 F (0.90 mm)	105	0.025” (0.64 mm)	0.021” (0.53 mm)	Straight
DK27_130	234053	2.7 F (0.90 mm)	130	0.025” (0.64 mm)	0.021” (0.53 mm)	Straight
DK27_150	232886	2.7 F (0.90 mm)	150	0.025” (0.64 mm)	0.021” (0.53 mm)	Straight
DK28_105	232890	2.8 F (0.93 mm)	105	0.027” (0.69 mm)	0.021” (0.53 mm)	Straight
DK28_130	234076	2.8 F (0.93 mm)	130	0.027” (0.69 mm)	0.021” (0.53 mm)	Straight
DK28_150	234547	2.8 F (0.93 mm)	150	0.027” (0.69 mm)	0.021” (0.53 mm)	Straight

Documentation

Drakon Peripheral Microcatheter Brochure

Drakon Peripheral Microcatheter Sales Sheet

Drakon Peripheral Microcatheter IFU

Disclaimer

Drakon^TM
Peripheral Microcatheter
Read all instructions prior to use. To avoid complications, observe all warnings and precautions found in the complete device labeling and instructions for use.
Illustrations are for demonstration purposes- Not indicative of actual size or clinical outcome.

Caution: US Federal Law restricts this device to sale by or on the order of a physician

Indications for Use: The Drakon^TM microcatheters are intended for the infusion of contrast media into all peripheral vessels. The Drakon^TM microcatheters are also intended for drug infusion in intra-arterial therapy and infusion of embolic materials. The Drakon^TM microcatheters should not be used in cerebral vessels.

Contraindications: Generally, angiography or intravascular therapy is contraindicated for, but not limited to, the patients listed as follows: • 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.

Warnings: • Always flush the lumen of the guiding catheter and the microcatheter continuously with sterile heparinized saline solution prior to insertion. Residual contrast media or blood clots on the microcatheter surface reduce its lubricity, preventing smooth microcatheter movement. If flushing fails to restore surface lubricity, suspend the use of the microcatheter and remove it slowly and carefully, together with the guiding catheter. • Do not pull the microcatheter with excessive force. Pulling the microcatheter with excessive force may cause serious mechanical damage, which may necessitate retrieval. • Do not use excessive force when navigating the microcatheter or when advancing the guide wire through a kinked or blocked microcatheter. This may result in mechanical damage to the microcatheter and may cause damage to the blood vessels. • Do not forcefully advance the microcatheter in extremely tortuous vasculature. This may result in kinks in the microcatheter or damage to the blood vessels. • Manipulating the microcatheter and/or the guide wire against resistance may result in damage to the blood vessel, the microcatheter or the guide wire. If the situation is not able to be resolved, withdraw the entire system of the microcatheter with the guiding catheter. During the procedure, continuously monitor the manipulation and location of the microcatheter in the vessel by confirming the position of the microcatheter tip through a high-resolution fluoroscope and/or a digital subtraction angiography monitor. If any resistance is felt, do not advance or withdraw the microcatheter until the cause of resistance is determined through a high-resolution fluoroscope and/or a digital subtraction angiography monitor. • Do not soak or wipe the microcatheter with agents containing organic solvents, like antiseptic alcohol. It may damage the microcatheter or it may decrease the lubricity of the microcatheter. • The infusion pressure in this microcatheter must never exceed 8273 kPa (1200 psi). A pressure that is higher than this maximum may cause serious mechanical failure in the microcatheter. • The appropriate antiplatelet/anticoagulation therapy should be administered pre- and post-procedure in accordance with standard medical practice.

Precautions: • US Federal law restricts this device to sale by or on the order of a physician. • The microcatheter must only be used by physicians who are thoroughly trained in the intended procedures. • The entire procedure must be carried out in a sterile environment. • Before opening, verify that the sterile packaging has not been compromised or damaged in any way. • Before opening, ensure that the use-by date, printed on the label, has not expired. • Before starting the procedure, the microcatheter itself must be visually inspected for any kinks, bends or other mechanical irregularities. • Before use, the surface of the microcatheter must be completely wet with sterile heparinized saline solution to activate the hydrophilic coating. • Manipulation of the microcatheter must be constantly monitored through a high-resolution fluoroscope and/or a digital subtraction angiography monitor. • Refer to instructions for use information on any drugs and/or devices you may wish to use with this microcatheter to determine compatibility and to prevent microcatheter damage. • Before starting a procedure, ensure that all devices and tools are in acceptable working condition. • Choose the microcatheter size that is most suitable from a diagnostic and anatomical point of view. • This device is sterilized with ethylene oxide gas (EtO) and is intended for single use only. Do not re-sterilize and/or reuse this device, as this might lead to patient infection or injury. • Do not use if the unit package or the product has been damaged or soiled. • Use immediately after opening the package and dispose of safely following your local procedure for the disposable of medical waste. • Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.

References

^{1. Accurate Medical Therapeutics. (2018) TR-025 Flexibility Bench Test. Bench test results may not necessarily be indicative of clinical performance. Data on File.}^{2. Accurate Medical Therapeutics. (2018) TR-006 Torque Transmission Bench Test. Bench test results may not necessarily be indicative of clinical performance. Data on File.}^{3. Accurate Medical Therapeutics. (2018) TR-017 Trackability Bench Test. Bench test results may not necessarily be indicative of clinical performance. Data on File.}^{4. Accurate Medical Therapeutics. (2018) TR-015_03 Injected Substances Compatibility Test Report. Bench test results may not necessarily be indicative of clinical performance. Data on File.}

GU05201138

Drakon™ Peripheral Microcatheter