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Brief Summary Document - HCP
Product
Flexima Catheters – IFU number 51732549
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
The 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 medium
- Delivery of irrigation fluids to the ureter
- Drainage of fluids from the urinary tract
- Access, advancement, or exchange of ancillary devices including guidewires.
Contraindications
The Ureteral Catheters are in general contraindicated for use in patients unsuitable for catheterization.
Warnings
No known WARNINGS associated with the use of this device.
Precautions
For injection: Inject desired solution (contrast medium and/or irrigation fluid) through the luer injection hub. Injection of non-intended media may result in patient injury.
MRI Safety Information
The Ureteral Catheters are composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic, and pose no known hazards resulting from exposure to any MR environment. Therefore, they are 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.