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Brief Summary Document - HCP
Product
Occluder Occlusion Balloon Catheter – IFU 51972087
Rx Statement
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. 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
The Occlusion Balloon Catheters are indicated for use for temporary ureteral occlusion and applications including, renal opacification, dislodgment of calculi and preventative calculi migration.
Any use for procedures other than those indicated in instructions is not recommended.
Contraindications
None known.
Warnings
Refer to Instructions for Use for all applicable information on Warnings.
Precautions
This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
- As with other balloon catheters, the likelihood of infection increases with prolonged insertion. It is recommended that the maximum insertion time be kept under 24 hours.
Caution: Bleed catheter of all air before use in ureteral system.
Caution: When inflating the balloon, always inflate slowly. Fluoroscopic monitoring of the balloon during inflation is recommended. If loss of pressure from the balloon occurs during inflation or if balloon ruptures, immediately discontinue the procedure. Deflate the balloon, do not reinflate and remove carefully.
Caution: Do not use a high pressure injector. Maximum distal lumen pressure is 250 psi (17 atm/bar; 1723 kPa).
Caution: The larger the syringe diameter, the greater the suction that is applied.
Potential adverse events
The complications that may result from an occlusion balloon procedure include:
- Allergic Reaction
- Bladder Spasms
- Discomfort
- Edema
- Hematoma
- Hemorrhage
- Hypotension
- Infection
- Fever
- Sepsis
- Urinary tract Infection
- Inflammation
- Laceration
- Pain
- Perforation
- Tissue Damage
Adverse events may require additional medical or surgical intervention or prolonged procedure.