Amplatz Sheaths

Coloplast offers amplatz renal sheaths designed for renal dilation, maintenance of the nephrostomy tract, and easy passage of surgical instruments.

  • Sturdy construction
  • 30 Fr diameter; 17 and 19 cm length options
  • Packaged sterile; 5 EA / box
Item Inner Diameter Length Sales UOM EA / Sales UOM
RF3017 30 Fr 17 cm Retail Box 5
RF3019 30 Fr 19 cm Retail Box 5

 

Indications

Used during renal dilatation to provide and maintain a nephrostomy tract.

Contraindications

Some percutaneous renal procedures may be contraindicated in the following situations (unless the anticipated benefits outweigh the potential risks):

  • Uncontrolled haemostasis disorders.
  • Untreated urinary tract infection.
  • Malignant kidney or urinary tract tumor.

Do not use when, in the judgment of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions

  • The Amplatz sheath is compatible with surgical instruments up to a diameter of 10 mm.
  • It is the typical practice to choose a dilator diameter corresponding to sheath inner diameter.
  • Do not resterilize this product.
  • The risks and benefits of using Amplatz Sheath should be considered in patients.

Adverse Events

As with any dilation or percutaneous access creation, the use of the dilatation balloon and Amplatz sheath may be associated with several risks including, but not limited to:

  • Damage (perforation, tissue trauma) to the urinary tract, kidney, or neighboring organs, particularly if the instructions for use have not been complied with, and especially if the catheter or the sheath has been positioned without fluoroscopic control.
  • Bleeding when withdrawing the sheath.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings and precautions refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.

Complications from the use of this device should be brought to the attention of your Coloplast Representative and your physician.

For Rx Only

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Minneapolis, MN

05/28/2020

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