Direxion Handling Lab Poster (Training)

Direxion Handling Lab Poster (Training)
HANDLING THE DIREXION™ Torqueable Microcatheter
Open Plastic Tray
2
Remove Mandrel
3
Flush Hoop
4
Flush Microcatheter
PACKAGING
1
Grasp the metal insert and push away from the catheter
tip to remove the Direxion shape-retention mandrel.
Flush the Direxion packaging hoop with saline
prior to removal of the microcatheter.
Remove the Direxion hub from its plastic clip
and flush the inner lumen with saline.
Guidewire Support
Rotate to Release Tension
Loosen RHV
Don’t Push Down at 90˚
Always insert a guidewire for support prior to
advancing Direxion in the patient.
Rotate Direxion in the opposite way to release
tension if resistance is felt when torquing the hub.
Loosen the Y-adapter or rotating hemostatic valve
(RHV) prior to advancing Direxion in the patient.
Do not press Direxion into the procedure
bed during a hand injection.
PROCEDURE
Open the plastic tray around
Direxion’s pre-shaped tip.
Direxion and Direxion HI-FLO Torqueable Microcatheters
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions
for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.
INTENDED USE/INDICATIONS FOR USE: The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use.
The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature.
The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.
CONTRAINDICATIONS: None known.
WARNINGS: • Never advance or withdraw an intravascular device against resistance until the cause of resistance is determined by fluoroscopy.
Movement of the microcatheter or guidewire against resistance may result in damage or separation of the microcatheter or guidewire tip, or vessel
perforation. • This Direxion Microcatheter family is not intended for use in the coronary vasculature or neurovasculature. • The Direxion HI-FLO
Microcatheter is not designed for the delivery of embolic coils. • Use of excessive force to manipulate the microcatheter against resistance can cause a
fracture in the nitinol shaft. Take care not to over-torque the microcatheter, and to relieve any tension before withdrawal by rotating the microcatheter in
the opposite direction.
PRECAUTIONS: • This device should be used only by physicians thoroughly trained in percutaneous, intravascular techniques and procedures. • Do not
introduce the microcatheter without guidewire support as this may cause damage to the proximal shaft of the catheter. • Because the microcatheter may
be advanced into narrow sub-selective vasculature, repeatedly assure that the microcatheter has not been advanced so far as to interfere with its removal.
ADVERSE EVENTS: The Adverse Events include, but are not limited to: • Allergic reaction • Death • Embolism • Hemorrhage/Hematoma • Infection •
Pseudoaneurysm • Stroke • Vascular thrombosis • Vessel occlusion • Vessel spasm • Vessel trauma (dissection, perforation, rupture)
Peripheral Interventions
300 Boston Scientific Way
Marlborough, MA 01752-1234
www.bostonscientific.com
To order product or for more information
contact customer service at 1.888.272.1001.
© 2014 Boston Scientific Corporation
or its affiliates. All rights reserved.
PI-277314-AA NOV2014
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