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Brief Summary Document - HCP
Product
NaviGuide™ Percutaneous Access Needle - IFU number 51917350-01
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 Percutaneous Access Needle is intended to facilitate access into the renal pelvis, and to advance guidewires into the collecting system in an antegrade manner.
Contraindications
There are no known contraindications.
Warnings
If the guidewire must be withdrawn while the cannula is inserted, remove both cannula and wire as a unit to prevent the cannula from damaging the guidewire.
Precautions
- Before removing the inner stylet, confirm the stylet hub is fully unlocked by turning the hub a ¼ counterclockwise turn (as denoted by the visual cue on the top of the stylet hub) to ensure needle access is not inadvertently compromised.
- If urine cannot be confirmed, STOP, determine fluoroscopic position and reintroduce assembled NaviGuide Needle if needed.
Potential adverse events
The following are some of the complications which can result from the use of access needles:
- Allergic reaction
- Discomfort
- Edema
- Hematoma
- Hemorrhage
- Infection
- Fever
- Sepsis
- Urinary tract infection
- Inflammation
- Laceration
- Pain
- Perforation
- Tissue damage
Adverse events may require additional medical or surgical intervention, or result in a prolonged procedure.