PM-25274
Soprano / Soprano Dual Flex Hybrid Guidewires 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 to the medical device
This guidewire is not intended for use other than for endourologic procedures.
Contraindications to the endourologic procedure
- 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
These devices must only be used by trained and experienced physicians.
Potential Complications
The following incidents may occur when using guidewires: Kinking, looping, knotting, breakage, or entrapment of the guidewire in another device used concurrently requiring the removal of the assembly (wire-device) as a complete unit and leading to a loss of ureteral or renal access.
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 Patient
Physicians should advise patients of the risks associated with the procedure and to report any side effect immediately such as hematuria or signs of infection.
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
PM-24599 / Sep 2024
