DMR PTW 3.3 V-3 11-Nov-2013
Page 1 of 14
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© Copyright Baylis Medical Company Inc., 2007 - 2014
The Baylis Medical logo and ProTrack are trademarks and/or registered
trademarks of Baylis Medical Company Inc. in the United States of America
and/or other countries.
English
Carefully read all instructions prior to use. Observe all warnings and
precautions noted in these instructions. Failure to do so may result in patient
complications.
Baylis Medical Company relies on the physician to determine, assess and
communicate to each individual patient all foreseeable risks of the procedure.
CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY
OR ON THE ORDER OF A PHYSICIAN
I.
DEVICE DESCRIPTION
Baylis Medical
ProTrack
™ Pigtail Wires, from hereafter referred to as “pigtail
wires”, are compromised of a stainless steel core wire with a flexible, spiral
shaped stainless steel coil on the distal end. The Pigtail wire is offered in
several lengths including, 175 and 230 cm. The product is supplied sterile for
single use only.
NOTE:
Refer to product labeling for specific model information regarding
pigtail wire diameters, lengths and tip shapes.
II.
INDICATIONS FOR USE
The
ProTrack
™ Pigtail Wires are intended for use in percutaneous transseptal
procedures to introduce and position catheters and other interventional
devices within the left heart. The device is not intended for use in the coronary
arteries.
III.
WARNINGS
The pigtail wire is intended for single use only. Do not resterilize
and/or reuse.
The pigtail wire should only be used by a physician trained in
percutaneous, intravascular techniques and procedures. It is
important to follow the instructions for use prior to using this product.
The pigtail wire is supplied sterile and non-pyrogenic in an
unopened package and should be used under sterile conditions. Do
not use if the package has been damaged or opened.
Do not use the pigtail wire after the expiration date indicated on the
label. Discard pigtail wires that exceed the expiration date.
Always advance and withdraw the pigtail wire slowly.
Do not push, auger, withdraw or torque a pigtail wire against
resistance until the cause of the resistance has been determined.
Applying excessive force against unexpected resistance may cause
damage to the pigtail wire, interventional device and/or left atrium.
Do not allow the pigtail wire to remain in a prolapsed position as this
may result in damage to the pigtail wire.
Utilize proper techniques to prevent air from entering the catheter
system while removing and reinserting the pigtail wire. Improper
techniques could result in an air embolism.
The Instructions for Use supplied with all interventional devices to
be used in conjunction with Baylis Medical Pigtail wires should be
consulted for intended use, contraindications, warnings, precautions
and potential complications related to such devices.
When the pigtail wire is exposed to the vascular system, it should be
manipulated while under high-quality fluoroscopic observation.
Do not straighten the spiral distal tip of the wire more than 5 times
during a procedure.
IV.
PRECAUTIONS
This device is supplied sterile. Do not use if sterile barrier is
damaged.
Use extreme caution when withdrawing pigtail wires through metal
tip catheters, metal cannulas, or other sharp edges which may
compromise the integrity of the pigtail wire.
Use care when removing the pigtail wire from the dispenser to
reduce the possibility of pigtail wire damage.
Inspect the pigtail wire prior to use for coil separation, kinking,
appropriate distal tip flexibility or breakage. If the pigtail wire is
damaged or defective, do not use it. Using a damaged or defective
pigtail wire may cause vasculature damage and/or compromise
pigtail wire performance.
Confirm ancillary devices are compatible with the pigtail wire
diameter before use.
V.
POTENTIAL COMPLICATIONS
Potential complications associated with the use of the pigtail wire include, but
are not limited to:
Vessel dissection or perforation
Irritation to the vessel causing vessel spasm
Hemorrhage (bleeding)
Hematoma and other access site complications
Thrombus formation
Baylis Medical Company Inc.
5959 Trans-Canada Highway
Montreal, Quebec, Canada, H4T 1A1
Tel: (514) 488-9801/ (800) 850-9801
Fax: (514) 488-7209
www.baylismedical.com
EU Authorized Representative:
Quality First International
20 Eversley Road, Bexhill-on-Sea, East Sussex
TN40 1HE, United Kingdom
Tel: +44-(20)-8-522-1937
Fax: +44-(20)-8-522-1937
Instructions for Use
ProTrack™
Pigtail Wire