BRK Transseptal Needles

BRK™ and BRK™ XS Transseptal Needles

Rx Only. Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.

United States: Required Safety Information

Indications

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.
• This device is intended for one time use only; do not reprocess or reuse it. Note the product “Use by” date on the package. Any attempt to resterilize and reuse this system may compromise its integrity. Adverse effects of using nonsterile components may include, but are not limited to:
  • Local and systemic infection or reaction
  • Mechanical damage
  • Inaccurate functionality
• The materials identified below per product may cause allergic or hypersensitivity reactions. Persons allergic to these may suffer an allergic reaction to this product. Prior to its use on the patient, the patient should be counselled on the materials contained in the device and a thorough history of allergies must be discussed:
  • Stainless steel
  • Epoxy adhesive
  • Nickel chrome plated brass
  • Silicone high vacuum grease (Dupont)
  • Master bond
• Misuse of this device may result in serious complications.
• For both patients and laboratory staff, cardiac catheterization procedures present the potential for significant X‑ray exposure, which can result in acute radiation injury as well as increased risk for somatic and genetic effects due to the X‑ray beam intensity and duration of the fluoroscopic imaging. Carefully consider the use of this device in pregnant women.
   

Precautions

• Federal law (U.S.) restricts this device to sale by or on the order of a physician.
• Read directions prior to use.
• Inspect the package prior to use. Do not use if the package is open or damaged.
• Inspect all components before use.
• Store in a cool, dark, dry place.
• 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
• This device should be used by only those physicians who are specially trained in transseptal procedures, in a fully-equipped operational electrophysiology (EP) laboratory.
• Catheter advancement should be performed under fluoroscopic guidance to minimize the risk of cardiac damage, perforation, or tamponade. Compatible navigation and real time visualization systems may also be considered.
• 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 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.
• If pericardial or aortic entry occurs, do not advance the dilator over the needle. If the needle has penetrated the pericardium or aorta, it must be withdrawn. Monitor vital signs closely.
• There is a risk of air infiltration when withdrawing objects from the hemostasis valve of the sheath. Take precautions to prevent air infiltration by withdrawing objects slowly to prevent vacuum buildup in the sheath and fluoroscopically monitor the sheath during ensuing device insertion for the presence of air.
• After use, this device, its accessories, and packaging should be appropriately classified for disposal, e.g. biohazard, sharps, non-hazardous waste etc., and carefully disposed of in compliance with facility procedures and applicable laws and regulations.
• One or more components of this device may contain the following substance defined as CMR 1B in a concentration above 0.1% weight by weight: Cobalt: Chemical Abstracts Service (CAS) No. 7440‑48‑4;EC No. 231‑158‑0. Current scientific evidence supports that medical devices manufactured from cobalt alloys and stainless steel alloys containing cobalt do not cause an increased risk of cancer or adverse reproductive effects.
• One or more components of this device may contain the following substance defined as CMR 1A in a concentration above 0.1% weight by weight: Lead: Chemical Abstracts Service (CAS) No. 7439‑92‑1;EC No. 231‑100‑4. Current scientific evidence supports that medical devices manufactured from lead do not cause an increased risk of cancer or adverse reproductive effects.

Potential Adverse Events

Bleeding

• Hemorrhage/Bleeding
• Hematoma

Cerebral injury

• Asymptomatic cerebral emboli
• Stroke/cerebrovascular accident
• Transient ischemic attack (TIA)

Embolism

• Air embolism
• Foreign body embolism
• Pulmonary embolism
• Thromboembolism
• Thrombosis/thrombus

Cardiac perforation

• Cardiac tamponade
• Pericardial effusion

Cardiovascular injury  

• Valvular damage
• Aortic root puncture
• Atrial perforation

Conduction system disturbance

• SA node, AV node, or His-Purkinje system block
• Cardiac arrhythmias

Immunological reaction

• Anaphylaxis

Infection

• Pericarditis
• Endocarditis
• Pneumonia
• Sepsis

Pain/discomfort

• Pain, groin, chest (general chest pain not associated with MI)

Peripheral vascular injury

• Dissection
• Laceration
• Arteriovenous fistula formation
• Pseudoaneurysm formation

Hypotension

Superficial tissue injury