Percutaneous Access Needles/Chiba Needle® Brief Statement
Indications
Puncture of the renal cavities.
Contraindications
Some percutaneous renal procedures may be contraindicated in the following situations (unless the anticipated benefits outweigh the potential risks):
- Uncontrolled haemostasis disorders.
- Untreated urinary tract infection.
- Malignant kidney or urinary tract tumor.
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
This type of device must only be used by trained and experienced professionals having a thorough understanding of the technical principles, clinical applications, and risks associated with percutaneous renal access procedures.
The safety of some percutaneous renal procedures should be evaluated in pregnant women.
Do not resterilize this product. Reuse of this single use product may create a potential risk to the patient.
Potential Complications
The use of this device may be associated with several risks including, but not limited to:
- Bleeding/hematuria
- Damage (perforation) to the kidney, urinary tract or neighboring organs, particularly if the instructions for use have not been complied with, and especially if the procedure has been performed without image guidance control.
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 law (USA) restricts this device to sale by or on the order of a physician.
Minneapolis, MN
12/07/2021
PM-19616