EP003997S

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Indications, Safety, and WarningsThe Medtronic Brockenbrough™ curved needle is made up of an outer cannula and an inner stylet. The outer cannula is made of flexible thin-walled tubing. The inner stylet is solid, much stiffer and closely fitting, whose sharpened end protrudes 2 to 3 mm beyond the tip of the cannula.Indications for useThe Brockenbrough™ curved needle is used in conjunction with transseptal catheters to puncture the atrial septum to allow conducting a left heart catheterization procedure through the right atrium. The Brockenbrough™ curved needle is intended for single use only.ContraindicationsThe use of the Brockenbrough™ curved needle is contraindicated in patients with the following conditions:

Distorted anatomy due to congenital heart disease

Significant chest or spine deformity

The inability to lie flat

Ongoing anticoagulation

Marked atrial enlargement

Left atrial thrombus or tumor

Dilated aortic root

Previous patch repair of the interatrial septum

Warnings and precautions

The Brockenbrough™ curved needle is designed for use by physicians engaged in the practice of specialized invasive cardiology techniques. Use of this needle should be restricted to those specialists trained to perform transseptal procedures to minimize the complications associated with this procedure.

The Brockenbrough™ curved needle must be sharp to minimize the risk of puncturing the left atrial wall just after crossing the septum.

Use continuous pressure monitoring and repeated biplane fluoroscopy of the tip during any positioning, to minimize the risk of advancing the Brockenbrough™ curved needle into an undesired location and the subsequent bleeding that might occur.

Extreme caution should be used in patients with a small left atrium, to avoid puncture of the left atrial wall.

Never advance the Brockenbrough™ curved needle until the catheter is correctly positioned on the atrial septum to minimize the risk of advancing the needle into an undesired location.

Never advance a dilator, sheath or catheter until the Brockenbrough™ curved needle has clearly entered the left atrial cavity, as confirmed by a distinct left atrial pressure record and the tip of the needle is in the left atrium on fluoroscopy.

If a dilator, sheath or catheter are inadvertently advanced into the pericardial space, do not remove them until the patient is in surgery.

Do not reuse the Brockenbrough™ curved needle. The Brockenbrough™ curved needle must be discarded after one procedure. Its structural integrity and/or function can be impaired through reuse or cleaning. All parts are extremely difficult to clean after being exposed to biological materials, and adverse patient reactions can result from reuse.

The Brockenbrough™ curved needle has been gamma sterilized prior to shipment. Carefully inspect the package before opening. Damaged packages should be returned to Medtronic. The Brockenbrough™ curved needle cannot be resterilized.

Do not use the product after its expiration date.

At no time should the introducer or guide wire be advanced or withdrawn when resistance is met without first determining the cause by fluoroscopy and taking remedial action.

Ensure that the catheter is appropriate for the Brockenbrough™ curved needle being used.

After use, the Brockenbrough™ curved needle may be a potential biohazard. Handle and dispose of it in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.

See the device manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.MAJ_83945

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