In-Ka® Ureteral Balloon Dilatation Catheters

In-Ka® Ureteral Balloon Dilatation Catheters from Coloplast provide radial dilation of the urinary tract to facilitate the placement of surgical instruments during endoscopic procedures.

Dual Lumens

  • Balloon lumen is fitted with a stopcock for connection to an inflation device
  • Distal lumen is designed to pass a guidewire up to 0.035”
  • Distal tip can be used for infusion of contrast medium

Balloon

  • High pressure 17 ATM maximum burst pressure
  • 4-6 mm diameter options; 4 cm length
  • Includes two radiopaque markers for fluoroscopic visualization and more accurate positioning

Kit Configurations

  • BD40 kits include screw syringe with a manometer
  • BD41 kits include screw syringe with luer-lock
  • In-ka® balloon catheters are single-use and packaged sterile
Item Catheter Diameter Catheter Length Balloon Diameter Balloon Length Inflation Device Sales UOM EA / Sales UOM
BD4044 5 Fr 75 cm 12 Fr 4 cm Screw Syringe with Manometer KT 1
BD4045 5 Fr 75 cm 15 Fr 4 cm Screw Syringe with Manometer KT 1
BD4046 5 Fr 75 cm 18 Fr 4 cm Screw Syringe with Manometer KT 1
BD4144 5 Fr 75 cm 12 Fr 4 cm Screw Syringe with Luer Lock EA 1
BD4145 5 Fr 75 cm 15 Fr 4 cm Screw Syringe with Luer Lock EA 1
BD4146 5 Fr 75 cm 18 Fr 4 cm Screw Syringe with Luer Lock EA 1

 

Indications

In-Ka® ureteral balloon dilatation catheters are intended for:

  • Dilation of ureteral meatus and/or ureteral canal during endoscopic procedures
  • Treatment of ureteral stenosis

Contraindications

  • Any contraindication to endoscopy (untreated urinary tract infection).
  • 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

  • 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® Ureteral Balloon 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:

  • Hematuria
  • Damage to the urinary tract (tissue trauma, ureteral perforation), particularly if the instructions for use have not been complied with, and especially if the catheter has been positioned without fluoroscopic control.

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

04/23/2020

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