Balloon Urinary Catheters Brief Statement
BRIEF STATEMENT
Indications
Foley catheters: urethral urinary catheterization. Only straight 2-way Foley catheters with a maximum balloon volume of 15 ml may be used for the suprapubic approach (except for ribbed catheters). 3-way Foley catheters: urethral urinary catheterization and postoperative bladder irrigation-lavage.
Prostate catheters:
- Short-term drainage of bladder urine
- Postoperative bladder irrigation-lavage
- After prostate surgery: haemostasis of the prostatic fossa
Contraindications
Same as for urethral urinary catheterization and supra-pubic bladder drainage, and generally, known allergic reactions due to the device material (e.g. latex). Where indicated, some products contain latex.
Warnings and Precautions
This type of device must only be used by trained and experienced professionals.
Potential Complications
Several adverse events have been described with the use of balloon catheters. Some are related to the patient’s conditions, the others to the procedure or the device: Related to the patient: bladder irritation symptoms, pain, urinary tract infection, incrustation and stone formation. Related to the procedure: urinary tract trauma. Related to the device: leakage, balloon burst or deflation. Adverse events specifically related to the use of supra-pubic catheters have been described. Related to the patient: same as above and hematuria, any type of skin irritation. Related to the procedure: the potential adverse events are those observed with supra-pubic drainage, particularly if one forgets to check whether the bladder is full before puncturing it, among which peritoneal perforation with or without bowel perforation, misplacement/displacement. Related to the device: same as above and migration of the catheter, catheter knotting.
Advice to the Patient
The physician must inform the patient of the risks associated with the use of the device
The risks and benefits of using Balloon Urinary Catheters should be considered in patients
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events 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.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Minneapolis, MN
February 21, 2023
PM 16193
