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Brief Summary Document - HCP
Product
Dual Lumen Ureteral Catheter – IFU number 51494544
Rx Statement
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a skilled and 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
Ureteral Catheters are indicated for use for catheterization of the urinary tract during interoperative procedures, including but not limited to the following applications:
- Ureteral occlusion for injection of contrast media.
- Delivery of irrigation fluids to the ureter.
- Drainage of fluids from the urinary tract.
- Access, advancement, or exchange of ancillary devices including guidewires.
Contraindications
Ureteral catheters are in general contraindicated for use in patients unsuitable for catheterization.
Warnings
None known.
Precautions
- For injection: Inject desired solution (contrast medium and/or irrigation fluid) through the yellow lumen luer injection hub. Injection of non-intended media through the yellow luer injection hub may result in patient injury.
- Use with compatible guidewires (0.038 in (0.97 mm) or smaller) and other compatible accessories only. Use of the catheter with incompatible accessories may result in a prolonged procedure and/or patient injury.
MRI Safety Information
The Dual Lumen Ureteral Catheter is composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic, and pose no known hazards resulting from exposure to any MR environment. Therefore, it is considered MR Safe.
Potential adverse events
The adverse events which may result from ureteral catheter placement include, but are not limited to:
- Allergic reaction
- Avulsion
- Bladder spasms
- Edema
- Extravasation
- Fistula
- Hematoma
- Hematuria
- Hemorrhage
- Hydronephrosis
- Infection including sepsis and urinary tract infection
- Inflammation
- Laceration
- Obstruction
- Pain/ discomfort
- Perforation of kidney, renal pelvis, ureter, and/or bladder
- Peritonitis
- Renal insufficiency/ failure
- Tissue damage
- Toxicity
- Unretrieved device fragments
- Urinary retention
- Urinary symptoms including dysuria, incontinence, and urgency
Adverse events may require additional medical or surgical intervention.