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Zurpaz™ 8.5F Steerable Sheath

Indications, Safety, and Warnings


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INDICATIONS FOR USE

The Zurpaz Steerable Sheath is indicated for use when introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.

CONTRAINDICATIONS

Do not use this device: Patients who do not tolerate anticoagulation therapy; Known or suspected atrial myxoma; Recent cerebral vascular accident (CVA); Myocardial infarctions within the last two weeks; Patients with an active infection; Unstable angina; Presence of atrial thrombus; Previous intra-atrial septal patch.

WARNINGS

Do not alter this device in any way. Only those physicians who are trained in transseptal procedures and catheter delivery systems should use this device. Do not reuse this device. Thorough cleaning of biological and foreign material is not possible. Adverse patient reactions may result from reuse of this device. After use, dispose of product and packaging in accordance with hospital administrative and/or local government policy. Maintain continuous hemodynamic monitoring throughout the procedure. Always observe acceptable hemodynamics prior to advancing the dilator or any other component. Always withdraw components/aspirate slowly to minimize the vacuum created during withdrawal. From the side port only - aspirate all air prior to fluid infusion. During radiofrequency (RF) ablation, position the ablation catheter so that the ablating tip and at least one ring electrode are exposed beyond the distal tip of the sheath to reduce the incidence of thermal deformation of the soft tip. Thermal deformation of the sheath tip may result in patient injury and/or damage to the sheath or to the other devices used concurrently. Provide continuous heparinized saline infusion while the sheath remains in the vasculature. Fibrin may accumulate in or on the sheath tip during the procedure. To prevent dislodgement of potential thrombus, aspirate when removing dilator or catheter. Prior to removing the steerable sheath, reinsert the guidewire through the sheath, reintroduce the dilator over the guidewire, straighten the sheath, then remove the dilator, guidewire, and sheath as a unit. Maximum in vivo time: 7 hours.

PRECAUTIONS

Carefully reading the Instructions before use of this device will help to reduce the potential risks and complications associated with the transseptal technique such as air emboli and/or perforation of the aorta and left atrium. Inspect all components before use. Do not use if the sterile package or items in the sheath set appear to be damaged or defective. The recommended diameter of any catheter inserted into the sheath is 8.7F (2.81 mm). The sheath inner diameter is 9F (3 mm). Do not attempt to insert a catheter having a distal tip or body size larger than the sheath size indicated. The steerable sheath is designed to interlock only with the Zurpaz sheath dilator. Misuse may result in serious complications. Do not attempt to use a guidewire larger than the maximum diameter specified on the package label. Prior to inserting the device into the patient, pre-assemble the steerable sheath and dilator. During insertion, use caution not to create excessive bends in this device. Frequently aspirate and saline flush the sheath to minimize the potential for thrombus formation. Do not remove dilator or catheter rapidly. Damage to the hemostasis valve may occur. Do not deflect the device beyond 180° prior to insertion of a catheter. If resistance is met when advancing or withdrawing guidewire or sheath, determine cause and correct before continuing with this procedure. Indwelling percutaneous introducer sheaths should always be supported with a catheter. Aspirate slowly, only from the side port. Inject or saline flush only from the side port. Certain conditions may require special consideration when using this product. These may be, but are not limited to Enlarged Aortic Root, Small Left Atrium, Marked Right Atrial Enlargement, Marked Distortion of the Thorax Configuration (i.e. Kyphosis or Scoliosis). STORE IN A COOL, DARK, DRY PLACE.

POTENTIAL ADVERSE EVENTS

Adverse events may vary in severity and may require medical or surgical intervention. These potential adverse events may include, but are not limited to: Arrhythmias, cardiac tamponade, effusion (pericardial), embolism, hematoma, hemorrhage, infection (local/systemic), intimal tear, myocardial infarction, lead displacement, patient foramen ovale (PFO), perforation, thrombus formation, valvular damage. Please consult the respective manufacturer’s labeling for adverse events associated with the use of either cardiovascular catheters and/or endomyocardial biopsy devices.

CAUTION

Federal Law (USA) restricts this device to sale by or on the order of a physician. Carefully read all instructions prior to use. Observe all contraindications, warnings, and precautions noted in these instructions. Failure to do so may result in patient complications. Boston Scientific relies on the physician to determine, assess, and communicate to each patient all foreseeable risks of the procedure.

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