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Indications, safety, and warnings

Navigator Flex Ureteral Access Sheath

Back to Navigator Flex Ureteral Access Sheath

Brief Summary Document — HCP

Product

Navigator™ Flex – IFU 52070049-01

Rx statement

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.

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

Navigator Flex Ureteral Access Sheath Set is intended to be used in establishing a conduit during endoscopic urological procedures, to facilitate the passage and use of endoscopes and other instruments into the urinary tract, and to remove urinary stones through the use of suction.

Contraindications

  • Patients who are contraindicated for retrograde urological procedures.  
  • Patients who have untreated urinary tract infections or any other condition which may lead to a high viscous flow within the kidney. 

Reuse Warning

Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

Warnings

Use continuous negative pressure during suction at 120 mmHg to 200 mmHg. Use continuous pressurized irrigation of 150 mmHg to 250 mmHg. Make sure all connections are secure and free of kinks, to prevent loss of negative pressure.

Precautions

Refer to Navigator™ Flex Instructions for Use for all applicable information on Precautions.

Potential adverse events

Potential adverse events associated with the use of the Navigator Flex Ureteral Access Sheath Set include, but are not limited to:

  • Allergic reaction 
  • Avulsion 
  • Dyspareunia 
  • Dysuria 
  • Edema 
  • Fistula 
  • Hematuria 
  • Hemorrhage or Hematoma 
  • Hydronephrosis 
  • Infection 
  • Inflammation 
  • Injury (Not otherwise specified) 
  • Laceration 
  • Pain/Discomfort 
  • Perforation (ureter, renal pelvis, or bladder) 
  • Prolonged procedure 
  • Renal Insufficiency 
  • Stenosis 
  • Tissue Damage 
  • Unretrieved device fragments 
  • Urinary symptoms, such as urgency and retention

Adverse events may require additional medical or surgical intervention. Any serious incident that occurs in relation to this device should be reported to Boston Scientific and the relevant local regulatory authority.