In-Ka® Nephrostomy Balloon Catheters

In-Ka® Nephrostomy Balloon Catheters from Coloplast provide uniform dilation of tissues throughout the length of the nephrostomy tract and allow for convenient placement of a working sheath.

Catheter

  • Short, tapered, and open tip allows for atraumatic dilation of the parenchyma
  • Channels allow for insertion of 0.035” or 0.038” guidewire
  • Inflation channel is fitted with a stopcock

Balloon

  • Designed for uniform dilation of the tissues throughout the duct wall
  • 17 ATM maximum inflation pressure

Kit Configurations

  • All kit configurations are supplied with a pre-fitted radiopaque Amplatz sheath
  • BD3020 kit includes a manometer with precise pressure control
  • Individually packaged; sterile
Item Catheter Diameter Catheter Length Balloon Diameter Balloon Length Amplatz Sheath – Inner Diameter Amplatz Sheath Length Inflation Device
BD3010 7 Fr 55 cm 30 Fr 12 cm 30 Fr 17 cm Screw type syringe
BD3020 7 Fr 55 cm 30 Fr 12 cm 30 Fr 17 cm Screw type syringe with Manometer

 

Indications

For dilation of the tract to create a percutaneous renal access.

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 judgement of the physician, such a procedure would be contrary to the best interest of the patient.

Warnings and Precautions

  • Amplatz sheath is compatible with surgical instruments up to a diameter of 10 mm.
  • Never inflate the balloon with air or gas.
  • Do not exceed the maximum rated burst pressure (17ATM)
  • Do not inflate balloon catheter while the balloon is directly beside and in contact with a stone
  • Do not resterilize this product.
  • The risks and benefits of using In-Ka® Percutaneous Balloon Dilatation Catheters should be considered in patients.

Adverse Events

As with any dilation procedure, the use of a dilatation balloon 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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