Baylis Medical SureFlex Instructions For Use Manual

Instructions for Use

®
SureFlex Steerable Guiding Sheath
English ................................................................ 1
Francais .............................................................. 2
Deutsch .............................................................. 4
Nederlands ......................................................... 6
Italiano ................................................................ 7
Español ............................................................... 9
Português ......................................................... 10
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
© Copyright Baylis Medical Company Inc., 2016-2018
The Baylis Medical Company logo and SureFlex are trademarks and/or registered
trademarks of Baylis Medical Company Inc. in the USA 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
DEVICE DESCRIPTION
The SureFlex Steerable Guiding Sheath kit consists of three components: a
sheath, a dilator, and a J-tipped guidewire.
The SureFlex Steerable Sheath is designed for safe and easy catheterization and
angiography of specific heart chambers and locations.
superior torque control and is flexible. The radiopaque tip maximizes visualization
of the sheath during manipulation.
The dilator provides support for the sheath and has a tapered tip.
INDICATIONS FOR USE
The SureFlex Steerable Guiding Sheath kit is indicated for introducing various
cardiovascular catheters to the heart, including the left side of the heart through
the interatrial septum.
WARNINGS
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Laboratory staff and patients can undergo significant x-ray exposure during
interventional procedures due to the continuous usage of fluoroscopic
imaging. This exposure can result in acute radiation injury as well as
increased risk for somatic and genetic effects. Therefore, adequate measures
must be taken to minimize this exposure.
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The SureFlex Steerable Guiding Sheath kit is intended for single patient use
only. Do not attempt to sterilize and reuse the SureFlex Steerable Guiding
Sheath kit. Reuse can cause the patient injury and/or the communication of
infectious disease(s) from one patient to another. Failure to follow this
instruction so may result in patient complications
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Care should be taken to ensure that all air is removed from the sheath before
infusing through the side port.
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Care should be taken when removing the dilator and catheters from the
sheath.
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Do not attempt direct percutaneous insertion of the sheath without the dilator
as this may cause vessel injury.
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Damage to guidewire may result if withdrawn through a metal needle cannula.
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Maintain continuous hemodynamic monitoring throughout procedure
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PRECAUTIONS
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ADVERSE EVENTS
Adverse events that may occur while using the SureFlex Steerable Guiding
Sheath include:
INSPECTION PRIOR TO USE
Prior to use of the SureFlex Steerable Guiding Sheath kit, the individual
components should be carefully examined for damage or defects, as should all
equipment used in the procedure. Do not use defective equipment. Do not reuse
the device.
EQUIPMENT REQUIRED
Intracardiac puncture procedures should be performed in a sterile environment in
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a specialized clinical setting equipped with a fluoroscopy unit, radiographic table,
physiologic recorder, emergency equipment and instrumentation for gaining
vascular access.
SUGGESTED DIRECTIONS FOR USE
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1. Preparing for Insertion
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The sheath provides
2. Inserting Sheath and Dilator
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3. Guiding Sheath/Dilator Assembly
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Provide continuous heparinized saline infusion while the introducer remains
in vessel.
To minimize vacuum effects during withdrawal, remove components/aspirate
slowly.
Avoid contact with liquids other than blood, isopropyl alcohol, contrast solution
or saline.
Prior to steerable sheath's delivery and removal, ensure distal section is as
straight as possible.
Do not kink, stretch or severely bend steerable sheath.
Do not use surgical instruments to handle sheath.
Careful manipulation must be performed to avoid cardiac damage, or
tamponade. Sheath, dilator and guidewire advancement should be done
under fluoroscopic guidance. If resistance is encountered, DO NOT use
excessive force to advance or withdraw the device.
The SureFlex Steerable Guiding Sheath kit is supplied STERILE using an
ethylene oxide process.
The sterile packaging and all components should be visually inspected prior
to use. Do not use the device if it has been compromised or damaged.
Do not attempt to use the SureFlex Steerable Guiding Sheath kit before
thoroughly reading the accompanying Instructions for Use.
Only physicians thoroughly trained in the techniques of the approach to be
used should perform interventional procedures.
Do not use device after its "Use By" date.
Avoid deflecting distal end of sheath during delivery and removal, otherwise
damage to vessels may occur.
Infection Air embolus
Local nerve damage Vasovagal reaction
Dissection Vessel spasm
AV fistula formation Atrial septal defect
Pseudoaneurysm Aortic puncture
Arrhythmias Perforation and/or tamponade
Hematoma Hemorrhage
Catheter entrapment Thromboembolic events
Stroke Valve damage
Myocardial infarction Pacemaker/defibrillator lead displacement
Pulmonary edema Coronary artery spasm and/or damage
Vessel trauma Pericardial/pleural effusion
Carefully read all instructions prior to use. Failure to do so may result in
complications.
Remove sterilized equipment from kit in sterile environment
Verify proper deflection of steerable sheath by using knob.
Insert steerable sheath only when distal end is completely straight.
Thoroughly flush the sheath, guidewire and dilator with heparinized saline
solution prior to use.
Perform a standard vein puncture using an access needle (not supplied).
Introduce the guidewire and advance to required depth. If resistance is
encountered, DO NOT use excessive force to advance or withdraw the
guidewire. Determine the cause of resistance before proceeding.
Leaving the guidewire in place, withdraw the needle.
Enlarge the cutaneous puncture site as necessary.
Assemble the dilator and sheath until the dilator hub locks into the sheath hub.
Thread the dilator/sheath assembly over the guidewire using a slight twisting
motion under fluoroscopic guidance.
Use standard technique to position the sheath/dilator assembly into the
desired heart chamber.
Turn steerable sheath knob in direction of desired distal deflection. Sheath
stays in desired position until sheath handle is turned again.
If resistance is encountered, DO NOT use excessive force to deflect the
sheath.
If transseptal puncture is required, refer to the Instructions for Use of the
transseptal puncture device.
Ensure the sheath is clear of air. To aspirate blood, use the sheath side port.
Monitor the location of the radiopaque tip frequently under fluoroscopy.
Deliver a continuous heparinized solution infusion or aspirate periodically.
This may help reduce the risk of thromboembolic complications due to
thrombus formation, as there may be a possibility of thrombus development
DMR TSK 3.3 V-6 13-Sep-2018