St. Jude Medical BRK Instrucciones De Uso página 3

State: Released Date: 2020.07.13 23:03 GMT Effectivity: Upon Release
English
See product catalog for reorder numbers.
Read Instructions for Use prior to use of this device.
See individual sterile package label for contents.
Single-use disposable medical device. Contents are sterile if package is unopened and undamaged. Do
not resterilize.
The instructions for use is recyclable. Dispose of used product and packaging following standard solid
biohazard waste procedures.
PACKAGE CONTENTS
The BRK™ Transseptal Needles are supplied sterile. The needle is packaged with a stylet inserted. The needle and stylet are
placed in the primary packaging. The primary packaging is placed inside a Mylar‡ and Tyvek‡ pouch, which is heat-sealed. The
pouch and this IFU are then placed in a box, which is sealed at both ends. Both the pouch and the box have a label with product
information, including the expiration date. Products are labeled for a shelf life of three years.
DESCRIPTION
The BRK™ Transseptal Needle consists of a luminal stainless steel needle and solid stainless steel stylet. The distal section of
the needle is curved to facilitate positioning within the heart when used with a St. Jude Medical transseptal sheath set. Within
this curved section, there is an abrupt step down in the outer diameter of the needle to mate with the internal diameter of the
dilator of a St. Jude Medical transseptal sheath set. The distal tip of the needle is beveled to facilitate the puncture process.
The proximal end of the needle is configured with a pointer flange (indicating distal curve orientation) and is fitted with a 2-way
stopcock to provide needle lumen access for aspiration, fluid injection/infusion, blood sampling, pressure monitoring, and
stylet and/or guidewire insertion (0.014" maximum guidewire diameter for an 18 gauge needle; 0.012" maximum guidewire
diameter for a 19 gauge needle). The stylet is straight and isodiametric throughout its length. The proximal end of the stylet
is fitted with a curved clip to lock onto the proximal needle hub when inserted into the needle lumen. The stylet is designed
to facilitate needle advancement within the dilator. The needle is available in various useable lengths and distal curve
configurations.
INDICATIONS FOR USE
The BRK™ Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain
left heart access.
CONTRAINDICATIONS
• Previous interatrial septal patch or prosthetic atrial septal defect closure device.
• Any previous thromboembolic event.
• Known or suspected left atrial myxoma.
• Known or suspected myocardial infarction within the last two weeks.
• Unstable angina.
• Recent cerebral vascular accident (CVA).
• Patients who do not tolerate anticoagulation therapy.
• Patients with an active infection.
WARNINGS
• Do not alter this device in any way.
• Do not reuse this device. After use, thorough cleaning of biological and foreign material is not possible. Adverse patient
reactions may result from reuse of this device.
PRECAUTIONS
• Caution: Federal law (U.S.) restricts this device to sale by or on the order of a physician.
• Store in a cool, dark, dry place.
Special Patient Populations
Prior to the procedure, the patient must be hemodynamically stable. Certain conditions may require special consideration when
using this product. These may include, but are not limited to:
• Rotated Heart
• Enlarged aortic root
• Marked right atrial enlargement
• Scoliosis/kyphosis
• Abnormal left atrial geometry
• Congenital malformations
• Vascular malformations
• Inability to access the right atrium through the inferior vena cava
Procedural Considerations
• Carefully reading the Instructions before use of this device will help to reduce the potential risks associated with the
transseptal catheterization technique such as embolism or cardiovascular perforation.
• Only those physicians who are specially trained in transseptal procedures should use this device.
• Fluoroscopy should be used to confirm positioning throughout the procedure.
• Transseptal procedures should be performed only in facilities appropriately equipped and staffed to perform such
procedures. Lab capabilities should include, but are not limited to:
• Intracardiac pressure monitoring capabilities
• Systemic pressure monitoring
• Contrast media injection and management of untoward reactions to contrast media
• Pericardiocentesis
• Surgical backup
• Anticoagulation therapy and monitoring
• Maintain monitoring of vital signs throughout the procedure.
• Inspect all components before use.
• During insertion, check for excessive resistance as the tip of the needle advances through the curvature of the sheath/
dilator assembly. If there is any resistance to needle advancement, retract the needle, and assess components.
• During insertion, use caution not to create excessive bends in this device. This may inhibit advancement of the needle and
may result in inadvertent needle puncture of the dilator/sheath assembly.
• During insertion, always use the stylet to facilitate needle passage through the dilator/sheath assembly. Failure to use the
stylet may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly
or skiving of material from the inner surface of the dilator.
• This device is intended for one time use only. Do not reprocess or reuse. Reuse can cause patient injury and/or the
communication of infectious disease(s) from one patient to another.
POTENTIAL COMPLICATIONS
Complications that may occur during use of this device include, but are not limited to:
• Air embolism
• Cardiac perforation
• Cardiac tamponade
• Conduction system disturbances such as SA node, AV node, or His-Purkinje system block
• Hematoma or excessive bleeding at the vascular access site
• Reaction to contrast medium
• Stroke
• Thromboembolism
• Valvular damage
• Cardiac arrhythmias
DIRECTIONS FOR USE - TRANSSEPTAL PROCEDURE
1. PREPARE AND ASSEMBLE EQUIPMENT
• Remove contents from packaging.
NOTE: Do not assemble the sheath and dilator.
• Flush the dilator and sheath with heparinized saline.
• Close the sheath stopcock.
• Remove the stylet from the needle and flush the needle with heparinized saline.
• Insert the stylet into the needle and lock it onto the hub.
• Insert the dilator fully into the transseptal sheath.
2. ADVANCE SHEATH/DILATOR ASSEMBLY INTO SUPERIOR VENA CAVA.
• Obtain femoral venous access (right femoral preferred). OPT: A larger ( 2.5 French sizes greater than the transseptal
sheath) standard length sheath may be used to obtain and maintain venous access for device exchange and hemostasis.
• Introduce a 0.032", 150 -180 cm, 3 mm "J" tip guidewire into the superior vena cava (SVC).
NOTE: 0.032" is the maximum guidewire diameter that can be used with the dilator.
• Insert the sheath/dilator into the vein over the guidewire until the sheath tip is in the SVC. Orient the dilator tip medially.
3. POSITION THE NEEDLE/STYLET ASSEMBLY INSIDE THE SHEATH/DILATOR ASSEMBLY.
• Remove the guidewire from the dilator.
• Fully aspirate the dilator. Flush the dilator with heparinized saline.
• Separate the sheath and dilator by withdrawing the dilator approximately 5 cm (See Fig. 1). This will facilitate passage of the
needle curve through the rigid hubs of the dilator and sheath.
• Lock the stylet onto the hub.
• Insert the needle/stylet into the dilator. Advance the needle/stylet under fluoroscopy until it is approximately 2 cm from the
dilator tip inside the sheath (See Fig. 2).
BRK™ AND BRK-1™
TRANSSEPTAL NEEDLE
Instructions for Use
Fig. 1
Fig. 2
1
1. needle
2. stylet
3. dilator tip
4. sheath