Bard X-Force N30 - Page 2

2
X-Force
®
Nephrostomy Balloon Dilation Catheter
Instructions for Use
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Description
The X-
Force
®
Nephrostomy Balloon Dilation Catheter is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm)
balloon mounted on the distal tip. It has a radiopaque tip and a radiopaque marker beneath the balloon. The
lumen labeled with rated burst pressure (XX ATM) is for balloon ination. The other lumen allows the catheter
to track over a 0.038” (.97mm) diameter guidewire and can be used for monitoring of pressure or the infusion
of medication and/or contrast medium. Each balloon inates to a stated diameter and length at a specic
pressure – typically at 10 atm.
The balloon dilation catheter comes packaged with a refolding tool and a working sheath. It is available with or
without an ination device. It comes sterile and is for single use only.
Indications for Use
The X-
Force
®
Nephrostomy Balloon Dilation Catheter is recommended for use in the dilation of the nephrostomy
tract and for placement of the working sheath.
Contraindications
Do not use the X-
Force
®
Nephrostomy Balloon Dilation Catheter in the presence of conditions which create
unacceptable risk during the dilation of the nephrostomy tract.
Warnings:
• If resistance is felt when removing either the catheter or the guidewire from the working sheath, stop and
consider removing them as a single unit to prevent damage to the product. Applying excessive force to
the catheter can result in tip breakage or balloon separation.
• Do not use air or any gaseous substances as a balloon ination media, always use sterile liquid media.
• This is a single use device. Do not re-sterilize any portion of this device. Reuse and/or
repackaging may create a risk of patient or user infection, compromise the structural integrity and/or
essential material and design characteristics of the device, which may lead to device failure, and/or lead to
injury, illness or death of the patient.
Precautions:
• Only a physician who has an understanding of the clinical applications, technical principles and associated
risks associated with balloon dilation of the nephrostomy tract should use this device.
• After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted
medical practice and with applicable laws and regulations.
Potential Complications
The complications that may arise from a balloon dilation procedure include tissue trauma and perforation.
Inspection Prior to Use
The X-
Force
®
Nephrostomy Balloon Dilation Catheter is a sterile, single use device. Carefully inspect the
catheter and the sterile packaging for signs of damage that may have occurred during shipment. Do not use the
product if damage is evident.
Preparation of the Catheter
All X-
Force
®
Nephrostomy Balloon Dilation Catheters contain air in the balloon lumen. The air must be removed
to allow liquid to ll the balloon when it is inated.
1. Remove the protective sheath from the balloon.
2. Attach the ination device to the connector on the balloon lumen.
3. Open the stopcock, and draw back on the ination device to remove the air from the balloon catheter
4. Close the stopcock, remove the ination device, depress the plunger to remove any air and reattach to the
balloon catheter.
5. Repeat steps 3-4 until all air is removed from the balloon lumen.
Catheter Insertion
1. Prior to insertion, place the working sheath over the balloon and position it proximal to the balloon.
Note: Dilation procedures should be conducted under uoroscopic guidance with appropriate X-ray
equipment or direct vision.
2. Introduce the catheter carefully over a 0.038” (.97mm) guidewire and place it in the area that needs to be
dilated. Use the radiopaque marker to aid in proper positioning.
Caution: Do not advance or withdraw the catheter or guidewire against any signicant resistance. The
cause of the resistance must be determined uoroscopically and remedial action taken.
English