Navigator™ Ureteral Access Sheath Set

Prescriptive Information

The Navigator Ureteral Access Sheath is indicated for use in endocsopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.

Contraindications

Patients who are contraindicted for Retrograde urologic procedures; Presence of tight strictures which would limit use of the device; Presence of large obstructing distal ureteral stone.

Warnings

The recommendations given are meant to serve only as a basic guide to the utilization of this access sheath set. The ureteral sheath set should not be used without comprehensive knowledge of the indications, techniques and risks of the procedure.

To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement.

• DO NOT bend or kink the catheter prior to placement, to do so could damage the integrity of the catheter and result in patient injury.
• If resistance is encountered during advancement or withdrawal of the catheter, STOP. DO NOT continue without first determining the cause of the resistance and taking remedial action.
• DO NOT advance the sheath without the dilator in place, to do so could cause injury to the patient.

Potential Adverse Effects

Potential complications associated with the use of the transurethral access device include, but not limited to: mucosal irritation, inflammation and edema; uretheral strictures; acute bleeding or hemorrhage; urethral, bladder, or ureteral perforation; other injury to the urinary tract.

Cautions

To minimize resistance during advancement, ensure the hydrophilic coating on the dilator and sheath is activated with saline or sterile water prior to placement. DO NOT bend or kink the catheter prior to placement, to do so could damage the integrity of the catheter and result in patient injury. If resistance is encountered during advancement or withdrawal of the catheter, STOP. DO NOT continue without the dilator in place, to do so could cause injury to the patient. Caution: Federal law (U.S.A) restricts this device to sale, distribution and use by or on the order of a physician. Refer to the Directions for Use provided with this product for complete instructions, warnings, and precautions prior to using this product.