PROCEDURES WORLDWIDE1
With over 2.6 million procedures world wide1, the BRK™ Transseptal Needle, XS Series has demonstrated the consistency, reliability, and stability you rely on. Designed for seamless operation, all BRK Transseptal Needles integrate optimally with Abbott guiding introducers. Robust full-metal construction and user-inspired features offer quality performance, and expanded options promote procedural flexibility.
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The BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal procedure to gain left heart access.
The BRK Transseptal Needle (TSN) is contraindicated for 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 and Patients with an active infection.
Do not alter this medical device in any way. Do not reuse this medical device. After use, thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this medical device.
The clinical user of BRK TSN is cautioned that their use is restricted to sale by or on the order of a licensed physician. BRK TSNs must be stored in a cool, dark, and dry location. This device is intended for one time use only. Do not reprocess or reuse BRN TSNs. Reuse of BRK TSNs can cause patient injury. For special patient population: Prior to a surgical procedure employing a BRK TSN, the patient must be hemodynamically stable. Certain medical conditions may require special attention when using this medical device. These may include, but are not limited to the following: Rotated heart, Enlarged aortic root, Marked right atrial 0RA) enlargement, Scoliosis (a neuro-muscular condition influenced by other factors, although it appears to be a bone condition) or kyphosis (characterized by an abnormally rounded upper back), Abnormal left atrial (LA) geometry, Congenital cardiac malformations, Vascular malformations and Inability to access the right atrium (RA) via the inferior vena cava (IVC). Concerning procedural considerations: Users (physicians) of BRK TSNs should comply with the following precautions/cautions: Carefully reading the Instructions (IFU) before use of this device will help reduce the potential risks associated with the transseptal catherization 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. Laboratory/clinical facility capabilities should include, but are not limited to, having the following:
Pericardial Effusion, Cardiac Perforation, Tamponade and Perforation.
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Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.
Precautions
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The following pages are intended for medical professionals and provide information on the proper use of products (medical devices, etc.) of Abbott Medical Japan GK.
The information provided here is not intended to provide information to patients and the general public.
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