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Brief Summary Document - HCP
Product
Contour™ Injection Ureteral Stent Set: IFU 51694937-01
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 Ureteral Injection Stent is intended to facilitate drainage from the kidney to the bladder via placement endoscopically or fluoroscopically. Additionally, the Ureteral Injection Stent is intended to inject contrast and saline into the renal collecting system.
Contraindications
The Ureteral Injection Stent is contraindicated for use with the following procedures and/ or conditions:
- Poor surgical risk patients
- Unexplained hematuria
- Unrepaired ureteral avulsion
Warnings
None known.
Precautions
Not adhering to the following precautions could result in patient injury:
- Periodic radiographic, isotopic or cystoscopic examinations are recommended to evaluate stent efficacy and to observe for possible complications. When long-term use is indicated, it is recommended that indwelling time not exceed 365 days and that evaluations be performed at 90-day intervals post placement.
- Retrieval Line indwelling time is not to exceed more than 14 days. If longer stent indwelling time is anticipated, remove retrieval line before placement or prior to day 14.
Refer to Instructions for Use for all applicable information on Precautions.
Potential adverse events
The adverse events which may result from placement of ureteral stent include, but are not limited to:
- Reflux-GU (e.g. ureteral reflux)
- Occlusion/Obstruction (e.g. catheter, stent)
- Migration (e.g. dislodgement)
- Hemorrhage
- Infection (e.g. sepsis, peritonitis, urinary tract infection)
- Perforation (e.g. bladder, ureter, kidney, renal pelvis)
- Extravasation
- Encrustation
- Loss of renal function
- Edema
- Urinary symptoms (e.g. frequency, urgency, incontinence, dysuria, nocturia, hematuria)
- Pain/discomfort
- Stent fragmentation
- Fistula
- Hydronephrosis
- Stone formation
- Tissue damage
- Erosion