Read instructions for use in its entirety prior to use.

Single use only disposable medical device.

Rx Only: 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 exible thin walled tubing with

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 at

• Substantial deformity of the spine or chest

resterilize. Reuse, reprocessing or resteriliza-

tion 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, aect the

measurement accuracy, system performance,

or cause a malfunction as a result of the prod-

uct being physically damaged due to cleaning,

• Maintain continuous pressure monitoring

and repeated biplane uoroscopy 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.

404854004ZHP_001 ID 2023-06-30

Manufacturer:

Directions for Use

• Always ensure that the transseptal needle

has clearly entered the left atrial cavity by

conrming distinct left atrial pressure and u-

oroscopy 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

• Store in a cool, dark and dry place.

• Inspect all components prior to use.

• If resistance is met while advancing or with-

drawing the introducer or guidewire, uoros-

copy 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

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 ush the transseptal needle.

3. Inspect all components prior to use for integ-

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 inter-

atrial 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 cor-

rect location is conrmed using uoroscopy

(preferably biplane).

transseptal needle into the left atrium.

The transseptal needle is slowly removed.

Shelf Life: 3 years.

Contents non-pyrogenic

and sterilized using ethylene

oxide

Do not resterilize

Single use only / Do not

reuse

Manufacturer

Manufacturing date

Caution, read intructions for

use prior to use

Product number

Proximal gage

Distal gage

Store in a cool, dark and dry

place

Transseptal Needles

有限公司 MERIT MEDICAL SYSTEMS, INC.

注册人及生产企业住所：1600 West Merit

Pkwy South Jordan, UT 84095

说明书编制或修订日期： 2023年7月

FND-019-00 FND-019-01 FND-019-02

FND-019-03 FND-019-04 FND-019-05

Transseptal Needles