BLUEGRASS Surfacer Gebrauchsanweisung

Bluegrass Vascular Technologies, Inc.
Surfacer® Inside-Out® Access Catheter System
INSTRUCTIONS FOR USE
SURFACER DEVICE HANDLE
The table below defines symbols and wording on the Surfacer Device Handle.
Symbol Image Function
Indicates direction to turn the Needle Guide Knob to deploy the
"Out" Arrow
Needle Guide. The "Out" arrow is colored red.
The operator should exercise caution.
Indicates direction to turn the Needle Guide Knob to retract the
"In" Arrow
Needle Guide. The "In" arrow is colored green.
The Needle Guide must be fully retracted before the Delivery
Instrument is removed from the patient.
The angle indicators (0, 30, 60, and 90) indicate the cranial
Angle Indicator
angle in degrees (°) of the Needle Guide deployment. Angles
are indicated down the right side.
The left side provides a visual indicator of the corresponding
Needle Guide deployment angulation.
"Unlock" indicates the status of the Needle Wire. The Needle
"Unlock"
Wire must be unlocked to deploy the Needle Wire.
"Lock" indicates the status of the Needle Wire. The Needle Wire
"Lock"
must be locked to pull in the Exit Introducer into the body.
Needle Guide
As the Needle Guide is deployed the inset increasingly turns red.
Deployment
Red indicates that the Needle Guide is deployed and the operator
Indicator (Inset)
should exercise caution.
I. DEVICE DESCRIPTION
The Surfacer® Inside-Out® Access Catheter System (Surfacer® System) is designed to facilitate entry
and placement of central venous access catheters within the peripheral vasculature. The Surfacer®
System is comprised of four components: a Workstation (Workstation Sheath) for percutaneous
access to the femoral vein; a Delivery Instrument (Surfacer Device) which contains a Needle Wire and
Needle Guide which is advanced to the supraclavicular space; an Exit Target which provides
fluoroscopic guidance to mark the exit point; and an Exit (Peelable) Introducer which is introduced over
the Needle Wire to access the central venous system. The Surfacer® System facilitates the entry and
positioning of standard access catheters by establishing a transient passage across venous
occlusions. Once the access is obtained and a catheter is in place, the Surfacer® System is removed.
II. CONTENTS
The Surfacer® System is comprised of the following components:
1) One (1) Workstation (Workstation Sheath)
2) One (1) Delivery Instrument (Surfacer Device) - (Sheath, Needle Guide, Needle Wire, and a Handle)
3) Two (2) Exit Targets
4) One (1) Exit (Peelable) Introducer
The Surfacer® System, once in place, facilitates stable upper body central venous access that is
suitable for any conventional catheter.
III. INDICATIONS FOR USE
The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to
facilitate catheter insertion into the central venous system.
IV. CONTRAINDICATIONS
The Surfacer® System is contraindicated for patients with an occlusion of the right femoral vein, right
iliac vein or inferior vena cava, or acute thrombosis within any vessel to be crossed by the Surfacer®
System. Special precautions may be required for patients with coagulation disorders or on anti-
coagulation therapy.
The Surfacer® System is not intended to control, diagnose, monitor or correct a defect of the heart or
of the central circulatory system through direct contact with these parts of the body.
The Surfacer® System is not intended for use in the coronary or cerebral vasculature.
This device is not to be used in the arterial system.
ENGLISH
V. WARNINGS
1. Only physicians who have received appropriate training and are familiar with the principles,
clinical applications, complications, side effects and hazards commonly associated with
interventional procedures should use this device.
2. Appropriate institutional practices for prevention of infection during percutaneous procedures
should be practiced.
3. This device should be used only in institutions where emergency surgery can be performed.
4. Patients with severe anatomical tortuosity (scoliosis, lordosis, etc.) should be imaged before use or
do not use.
5. Once the patient is positioned flat on the table in a supine position, do not reposition or elevate
the torso or head while the Surfacer System is in the body.
6. The Workstation Sheath must be inserted to a stable position in the peripheral venous system.
7. The Surfacer Device should only be inserted through the recommended Workstation Sheath to
avoid damage to the patient or to the device during its use.
8. The Needle Guide must be retracted (withdrawn into the Surfacer Device) before the device can be
removed from the patient.
9. Orientation of the Needle Guide should be confirmed (under fluoroscopy) before it is advanced to
avoid complications including vascular damage, or other serious injury to the patient (refer to
section VI. Risks).
10. Peelable Introducer is not a hemostasis valve and is not intended to create a complete two-way
seal. It is designed to reduce air intake and blood loss.
VI. RISKS
Risks associated with using the Surfacer® System include risks associated with routine interventional
procedures and risks associated with the underlying patient condition.
The potential risks include, but are not limited to:
• Pain
• Infection
• Bleeding
• Adverse tissue reaction; allergic reaction
• Cardiovascular sequelae including: perforation, tamponade, spasm or effusion
• Lymphatic system sequelae
• Pulmonary sequelae including: pneumothorax, pulmonary embolism
• Vascular sequelae including vasospasm, vessel perforation, dissection, or aneurysm
• Unintended embolization or thrombosis
• Arrhythmias
• Neurologic sequelae including stroke; transient ischemic attack; nerve injury
• Death
• Surfacer® System component failure or malfunction
VII. PRECAUTIONS
General – Precautions
The Surfacer® System should only be used by physicians experienced with interventional procedures.
Prior to use, operators must review the Instructions for Use and be familiar with techniques associated
with the use of the device.
Surfacer® System Handling – Precautions
• Store all Surfacer® System components in a location that is cool and dry.
• Inspect package prior to use. Do not use if the peel pouch is damaged or opened or if the contents
appear to be damaged.
• For SINGLE USE ONLY. Do not re-sterilize or reuse. Re-sterilization or cleaning may damage the
device and impair the performance of the Surfacer® System.
• Use the product prior to the "Use By" date.
• Use sterile techniques at all times when handling the Surfacer® System.
Use in Specific Patient Populations – Precautions
Do not use the Surfacer® System in patients for whom this procedure is contraindicated.
Post-Procedure – Precautions
Employ proper access site management per institutional protocol post-procedure and post hospital
discharge to maintain patency and prevent infection.
VIII. BASELINE PARAMETERS
Perform baseline venography or optional venous duplex of the upper body veins (SVC, jugular,
inferior vena cava (IVC), brachiocephalic and subclavian).
Perform baseline anterior posterior (AP) and lateral chest x-ray with contrast to define the pattern of
occlusions and to rule out acute thrombus.
Evaluate pre-procedural screening diagnostics and confirm supraclavicular exit location.
IX. COMPONENTS
The specific components of the Surfacer® System are described as follows:
1. Workstation Sheath - the Workstation Sheath provides access to the peripheral venous system via
the right femoral vein. The Workstation Sheath provides a lumen for the Surfacer Device, preventing
injury when it is advanced. Users have reported double sheathing or using reinforced introducer
sheaths when necessary. Refer to Surfacer System Training Manual for further information.
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