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Brief Summary Document - HCP
Product
UroMax Ultra™ High Pressure Balloon Catheter - IFU number 51938384-01
Rx Statement
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner.
CAUTION: The law restricts these devices to sale by or on the order of a physician.
Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for
INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.
Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.
Intended Use/Indications for Use
Balloon Dilatation Catheters are recommended for dilatation of the urinary tract.
Contraindications
None known.
Warnings
None known.
Reuse Warning
For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
Precautions
- Do not advance the balloon catheter if resistance is encountered. Forceful insertion may result in patient injury.
- Verify that the appropriately sized balloon is used, and do not inflate the balloon past the rated burst pressure stated on the label. Overinflation may result in overdilation of the patient’s urinary tract and damage to the balloon catheter, resulting in device fragments that may be difficult to retrieve.
- Do not inflate balloon dilatation catheter while the balloon is directly beside and in contact with a stone.
- Doing so may cause migration of the stone further up the urinary tract and result in patient injury, prolongation of the planned procedure or the need for additional procedures.
- Before inflating the device, confirm desired position by visualizing the balloon catheter under fluoroscopy, to avoid damage to the urinary tract.
- Ensure the balloon catheter is fully deflated by applying suction to the stopcock connector with an inflation device or syringe before removing it from the patient. Do not withdraw the balloon catheter if resistance is encountered. Failure to fully deflate the balloon may result in patient injury.
- Care should be exercised when passing a balloon coated with HydroPlus Coating through any metal containing system. Do not wrap gauze around the balloon. Minimize excessive handling. Do not wipe balloon with dry gauze or gauze wet with any solvent other than sterile water or saline.
- Inflation devices and syringes are capable of attaining very high pressures with minimal effort. The use of an inflation device or syringe with a high pressure gauge is strongly recommended.
- If loss of pressure within the balloon occurs during inflation or if balloon ruptures during dilatation, immediately discontinue the procedure. Deflate the balloon carefully. Do not reinflate.
- If resistance is encountered when removing a guidewire through a catheter or if resistance is encountered when removing a catheter through a scope, STOP and remove them as a complete unit to prevent damage to the guidewire, catheter or anatomy.
Potential adverse events
The complications which may result from a balloon dilatation procedure include:
- Allergic reaction
- Dysuria, retention and urgency
- Fistula
- Hematoma
- Hemorrhage
- Infection
- Inflammation
- Injury to the urinary tract
- Obstruction (including from unretrieved device fragments)
- Pain and discomfort
- Perforation / avulsion
- Stricture
- Tissue damage
Adverse events or device malfunction may result in prolonged procedure or additional interventions.