PFM Medical Multi-Snare Instrucciones De Uso página 4

English
Indications (USA and Canada Only)
• Retrieval and manipulation of foreign objects from the vascular system and hollow viscera.
• Assistance in creating loops where cross-over technique is applied.
• Repositioning of indwelling venous catheters.
• Assistance in performing venipuncture to obtain access to central vein.
Contraindications
The snare may not be used
• For removal of foreign bodies that have become entrapped by tissue overgrowth.
• For removal of implanted pacing leads.
• For fibrin sheath stripping in the presence of septal defects of persistent Foramen Oval (Reason: Risk of Cross embolism).
Possible Complications
• Air embolism
• Death
• Haematoma at the puncture site
• Infection
• Perforation of the vessel wall
• Pulmonary embolism because of "lost" fibrin sheath material, especially when the fibrin sheath is long, and big
Directions for use
Selection of the snare, and preparation
The maximum snare diameter (see label) should not exceed the targeted vessel diameter.
Remove the snare from the protective transport dispenser. Take care that the proximal end of the snare does not cross the mark on the
connected insertion aid.
Carefully inspect snare (and snare catheter) for any damages.
Note: It is recommended to use the pfm medical Multi-Snare® or Multi-Snare® Micro together with a pfm medical snare catheter.
Note: Prior to use thoroughly flush the snare catheter, and the Multi-Snare® / Multi-Snare® Micro with sterile heparinized saline solution.
An additional systemic application of heparin is recommended.
Introduction
Disconnect the insertion aid from the transport dispenser, and connect it with the snare catheter or another suitable catheter.
Note: We advise you that the insertion aid was specially optimized for the compatibility with the pfm medical snare catheter.
Insertion without guide wire
The snare catheter is inserted into the human body via an introducer sheath or a big vascular cannula with haemostatic valve.
Insert the snare using the insertion aid provided into the snare catheter which is already positioned in the vascular system, and place it
proximally to the foreign body. For an eased manipulation and torqueability of the snare the provided torquer should be mounted at the
proximal end of the Multi-Snare®.
In general it is recommended to insert first the snare catheter to the region of interest. It is also possible to introduce the snare catheter
with the preloaded snare as a unit.
Insertion over a guide wire
Note: Check whether the guide wire or guiding catheter have the necessary diameter, and length for catheter removal resp. to accommo-
date the snare. If necessary, replace with a suitable type.
Position the indwelling guide wire as close as possible to the foreign body. Place the snare loop over the proximal end of the guide wire,
and pull tight. Advance the snare into the guiding catheter or vascular cannula until the distal end of the snare catheter is positioned just
proximal to the foreign body.
Manipulation/Extraction of foreign objects
❶
Push the snare shaft carefully forward to open the loop. The open loop is then slowly advanced forward and placed around the proximal end
of the foreign body. The diameter of the snare can be adjusted within the determined limits by moving the snare catheter forward or backward.
❷
B y advancing the snare catheter, the snare loop is closed around the foreign body, and the foreign body is trapped.
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WA R N I N G S
Pulling back the snare can change the position of the snare loop.
❸
T o manipulate a foreign body, maintain tension on the snare catheter to retain the hold on the foreign body. Move the snare, and the
snare catheter as a unit, in order to manipulate the foreign body to the desired position.
❹
T o remove the foreign body, maintain tension on the snare catheter, and pull the snare and the snare catheter as a unit to the tip of
resp. into the guiding catheter or introducer sheath. The foreign body is then withdrawn through or together with the guiding catheter
or introducer sheath. The withdrawal of larger foreign bodies may require the exchange with larger sheaths, or guiding catheters, or a
comminution of the foreign body in the peripheral vascular system.
Snare Assisted Venous Canalization
❶
I ntroduce the snare at a patent venous access site, and position it at the new, desired venous access site in the vascular system.
❷
O pen the snare loop. The opened loop functions as a target to guide the puncture at the desired venous access site.
❸
I nsert the guide wire through the cannula, and the opened snare loop.
❹
P ull the snare tight around the cannula by advancing the snare catheter.
❺
P ull the guide wire into the inferior vena cava.
Snare Assisted Fibrin Sheath Stripping
❶
A dvance the snare to the desired place from a common femoral vein access through the Vena Femoralis.
❷
I nsert a suitable guide wire through the indwelling catheter, and forward it, until it exits the distal end.
❸
E ncircle the guide wire with the snare loop.
❹
A dvance the snare over the distal end of the catheter to a position proximal to the fibrin sheath.
❺
T ighten the snare around the catheter. Hold the diameter of the snare loop by continuing to apply light traction while gently pulling the
snare down (towards the distal end of the catheter) over the hub.
❻
R epeat steps 4, and 5 until the catheter is free of fibrin sheath.
WA R N I N G S
When using the snare for fibrin sheath stripping the user must ensure, that no high pulling force is applied to the
catheter. Too high pulling force may lead to the damage and failure of the product, e.g. stretching, breakage, etc.
Disposal after Use
After use, medical products and accessories pose a potential biological hazard. For this reason, the products and their accessories should
be handled and disposed of in accordance with recognised medical procedure, and in compliance with the relevant legal regulations and
local ordinances.
Warranty
Improper handling or use may damage the pfm medical Multi-Snare®. pfm medical disclaims all warranties, expressed and implied, inclu-
ding, but not limited to, any implied warranty of merchantability or fitness for a particular purpose. pfm medical shall not be liable to any
person or entity for any medical expenses or any direct, incidental or consequential damages caused by any defect, failure or malfunction
of the system, whether a claim for such damage is based upon warranty, contract, tort or otherwise.
19.04.2012_Rev04 19.04.2012_Rev04
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