Merit Medical HeartSpan Transseptal Needle - Manual (Page 3)

3
Precautions
• Store in a cool, dark and dry place.
• Inspect all components prior to use.
• If resistance is met while advancing or withdrawing the
introducer or guidewire, fluoroscopy should be used to
determine the cause.
• Prior to use, ensure the appropriate catheter is being used
with the transseptal needle.
Adverse Events
In addition to the complications associated with any cardiac
catheterization, the following could occur during a transseptal
catheterization:
• Inferior vena cava puncture
• Aorta puncture
• Atrial free wall puncture
• Coronary sinus puncture
• Arterial embolism from thrombus at the puncture site
• Tamponade
• Residual atrial septal defects
• Atrial arrhythmia
Directions for Use
1. To determine the size and location of the left atrial septum, it
may be helpful to perform right side angiography.
2. Thoroughly flush the transseptal needle.
3. Inspect all components prior to use for integrity and
appropriateness for the particular procedure.
4. The transseptal needle/stylet set is advanced through the
transseptal catheter and/or introducer until the tip of the
needle is just within the catheter. Note: Ensure the transseptal
needle is free to twist and/or rotate without resistance, as it is
advanced to this position.
5. Retract the stylet prior to puncturing the interatrial septum.
6. The tip of the transseptal needle is positioned against the
interatrial septum.
7. The transseptal needle is advanced through the septum into
the left atrium once the correct location is confirmed using
fluoroscopy (preferably biplane).
8. The successful puncture into the left atrium is confirmed by
observing a left atrial pressure tracing. If an incorrect pressure
tracing is observed, a small amount of contrast media is
injected to identify the positioning.
9. The transseptal catheter is advanced over the transseptal
needle into the left atrium.
10. The transseptal needle is slowly removed.
en - Directions for Use