Merit Medical HeartSpan Transseptal Needle - Manual (Page 2)

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R ead instructions for use in its entirety prior to use.
Single use only disposable medical device.
Caution: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
Device Description
The transseptal needle kit consists of an outer needle cannula and
an inner stylet. The needle is comprised of flexible thin walled tubing
with an ergonomic hub and stopcock attached to the proximal end.
The stylet consists of a solid wire that when inserted in the needle
protrudes beyond the distal tip of the cannula.
Indications for Use
The transseptal needle is used in conjunction with a transseptal
catheter and/or introducer to create the puncture in the atrial
septum to allow left heart catheterization procedure to occur
through the right atrium.
Contraindications
• Left atrial thrombus or tumor
• Dilated aortic root
• Continual anticoagulation
• Inability to lie flat
• Substantial deformity of the spine or chest
• Marked atrial enlargement
• Distorted anatomy due to congenital heart disease
• Previous intra-septum patch
Warnings
• For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which in turn may result in patient injury, illness or death.
This single-use product is not designed or validated to be
reused. Reuse may cause a risk of cross-contamination, affect
the measurement accuracy, system performance, or cause
a malfunction as a result of the product being physically
damaged due to cleaning, disinfection, re-sterilization, or
reuse.
• Only those physicians who specialize in the practice of
invasive cardiology techniques should use this device. The
device should be restricted for use by those specialists trained
to perform transseptal procedures.
• Maintain continuous pressure monitoring and repeated
biplane fluoroscopy during positioning.
• Caution should be used in patients with small left atrium, to
avoid left atrial wall puncture.
• The transseptal needle should never be advanced until the
catheter is positioned correctly on the atrial septum.
• Always ensure that the transseptal needle has clearly entered
the left atrial cavity by confirming distinct left atrial pressure
and fluoroscopy of the needle tip before advancing the
dilator, sheath or catheter.
• Do not remove a dilator, sheath or catheter that has been
inadvertently advanced into the pericardial space until the
patient is in surgery.
• Do not reuse this device. The device must be discarded after
one use using acceptable medical practices and applicable
local, state and federal laws and regulations.
• Follow instructions accompanying the transseptal
introducers.
en - Directions for Use