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Brief Summary Document - HCP
Products
Contour™ Ureteral Stents: IFU 51413322-01A
Percuflex™ Plus Ureteral Stent: IFU 51413322-01A
Percuflex™ Ureteral Stent: IFU 51413322-01A
Polaris™ Ultra Ureteral Stent: IFU 51413322-01A
Rx statement
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
This device is restricted to use by or under the supervision of physicians trained in endoscopic urological biopsy procedures.
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 Stents are intended to facilitate urinary drainage from the kidney to the bladder via placement endoscopically or fluoroscopically by a trained physician.
Contraindications
None known.
Warnings
None known.
Precautions
Not adhering to the following precautions could result in patient injury:
- Retrieval line (suture) indwelling time should not exceed fourteen (14) days to avoid possible line encrustation.
- Evaluate the stent periodically to ensure the stent is draining adequately and to observe for possible complications.
- Note: Stent indwelling time (with retrieval line (suture) removed) should not exceed 365 days*.
- Evaluate the stent on or before 90 days after placement, and at least every 90 days thereafter if long term use is indicated.
- Formation of knots in Variable Length ureteral stents may occur. This may result in injury to the ureter during removal and/ or the need for additional surgical intervention. The presence of a knot should be considered if significant resistance is encountered during attempts at removal.
Refer to Instructions for Use for all applicable information on Precautions.
*Data on file.
Potential adverse events
Adverse events associated with retrograde or antegrade positioned indwelling ureteral stents include but are not limited to:
- Allergic Reaction
- Avulsion
- Discomfort
- Dislodgement
- Edema
- Encrustation
- Erosion
- Extravasation
- Fistula
- Hematoma
- Hematuria
- Hemorrhage
- Hydronephrosis
- Infection
- Peritonitis
- Sepsis
- Urinary Tract Infection
- Inflammation
- Loss of Renal Function
- Migration
- Obstruction
- Occlusion
- Pain
- Perforation
- Reflux, Genitourinary (GU) (includes Ureteral Reflux)
- Stone Formation
- Tissue Damage
- Unretrieved Device Fragment
- Urinary Symptoms
- Dysuria
- Frequency
- Incontinence
- Nocturia
- Urgency
Adverse events may require additional medical or surgical intervention.