Soprano®/ Soprano® Dual Flex Brief Statement
Intended use
This device is intended to be used to facilitate the placement of endourological instruments during diagnostic or interventional procedures.
Indications
Endourological guidewires are used to facilitate the insertion of endoscopic and/or consumable devices or to keep the path of an access once a ureteral or a percutaneous access has been established.
Contraindications
This guidewire is not intended for use other than for endourologic procedures.
Untreated urinary tract infections.
Uncorrected haemostasis disorders.
The safety of some endourologic procedures should be evaluated in pregnant women.
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 device must only be used by trained and experienced physicians with a thorough understanding of the technical basics, clinical applications, and risks of using guidewires to prevent damage to the guidewires and patient harm. The users should be familiar with the appropriate techniques to manage the potential complications associated with the use of the device.
Failure to abide by the following warnings might result in abrasion of the hydrophilic coating, release of fragments from the guidewire, damage to or breakage/separation of the guidewire, or perforation of tissue that may necessitate intervention.
Any use other than the stated intended use is under the responsibility of the physician.
Potential Complications
The following side effects have been reported although their occurrence greatly depends on patients’ medical conditions. Side effects include but are not limited to: mucosal irritation, tissue lesion, bleeding (e.g., hematuria, hemorrhage), perforation of the urinary tract or close organs, infection (e.g., urinary tract infection, pyelonephritis, severe infection…), burns when in contact with an electrosurgical equipment, ureteral avulsion, and foreign object in body (which may additionally cause pain, dysuria, or frequency). Other unusual side effects may include allergic reactions to guidewire materials.
Advice to the Patient
The physician should educate the patient on his/her diagnostic or interventional procedure. The patient should be advised to inform the physician immediately if any side effect (e.g., blood in the urine, signs of infection) occurs.
The risks and benefits of using Soprano®/ Soprano® Dual Flex 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 law (USA) restricts this device to sale by or on the order of a physician
