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Brief Summary Document - HCP
Products
Percuflex™ Urinary Diversion Stent Set: IFU 51413325-01
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 Urinary Diversion Stent Sets are intended to provide external drainage of urine after urinary diversion surgeries.
Contraindications
None known.
Warnings
None known.
Precautions
Not adhering to the following precautions could result in patient injury:
- Evaluate the stent periodically to ensure the stent is draining adequately and to observe for possible complications.
- Evaluate the stent on or before 90 days after placement if long-term use is indicated.
- Note: Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days. This stent should be evaluated by the physician on or before 90 days postplacement.
Refer to Instructions for Use for all applicable information on Precautions.
Potential adverse events
Adverse events associated with Urinary Diversion 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 Leak
Adverse events may require additional medical or surgical intervention.