Indications

The VisiSheath Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The device is also intended for use in the introduction and support of intravascular catheters.

Contraindications

None known.

Warnings

Dilator sheaths should be used only at institutions with thoracic surgical capabilities by physicians knowledgeable in the techniques and devices for lead or catheter removal. When using dilator sheaths, do not insert sheaths over more than one lead or catheter at a time. Severe vessel damage, including venous wall laceration requiring surgical repair, may occur. Do not maintain a stationary position with the VisiSheath tip at the Superior Vena Cava (SVC) right atrial (RA) junction as it may result in damage to this delicate area during subsequent lead extraction and reinsertion procedures (e.g., manipulating the dilator sheath or implanting a new lead). Weigh the relative risks and benefits of intravascular lead/catheter dilation procedures, especially in cases when: the object to be dilated away from adherent tissue is of a dangerous shape or configuration; the likelihood of lead/catheter disintegration may result in increased risk of fragment embolization; vegetations are attached directly to the lead/catheter body.

Precautions

For single use only. The VisiSheath Dilator Sheath must not be resterilized and/or reused. Do not alter the sheath from its original state prior to use. When the VisiSheath Dilator Sheath is in the body, it should be manipulated only under fluoroscopic observation with radiographic equipment that provides high-quality images. Prior to the procedure, evaluate the physical dimensions of the lead, catheter, or inner sheath in relation to the specifications of the dilator sheath to determine possible incompatibility. If selectively removing leads/catheters with the intent to leave one or more chronic leads/catheters implanted intact, the non-targeted leads/catheters must be subsequently tested to ensure that they were not damaged or dislodged during the procedure. Maintain adequate tension and coaxial alignment on the lead/catheter to minimize the risk of vessel wall damage. If excessive scar tissue or calcification prevents safe advancement of dilator sheaths, consider an alternate approach. Excessive force with dilator sheaths used intravascularly may result in damage to the vascular system requiring emergency surgical repair. If the lead/catheter breaks, evaluate fragment for retrieval. If hypotension develops, rapidly evaluate; treat as appropriate. Due to rapidly evolving lead/catheter technology, this device may not be suitable for dilation of tissue around all types of leads/catheters. Do not pull on the lead/catheter because it may stretch, distort, or break, making subsequent removal more difficult. Damage to a lead may prevent passage of a lead locking device through the lumen and/or make dilation of scar tissue more difficult. If the dilator sheath fails to progress after initial success, or if advancing the sheath was difficult, remove the sheath to inspect the tip. If the tip is distorted or frayed, exchange the damaged sheath for a new sheath before continuing treatment. When advancing a sheath around a bend, keep the point of the sheath's beveled tip oriented toward the inside of the bend.

Please see complete Instructions for Use before using the VisiSheath. 2 MB