Boston Scientific accounts are for healthcare professionals only.
Brief Summary Document - HCP
Product
Percutaneous Access Needle - IFU number 51917354-01
NOTE: The TLA Needle and Sheath Set is not packaged with a DFU, as allowed by 21CFR 801.109 and MDD 93/42/EEC Annex 1, clause 13.1. These devices are for prescription use only and the indications, contraindications, directions, hazards, warnings, and other information are commonly known through physician training and widespread use of these devices to practitioners licensed by law to use them.
The indications, contraindications, directions, warnings, and all other statements on this page apply only to the product listed above.
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If the guidewire must be withdrawn while the cannula is inserted, remove both cannula and wire as a unit to prevent the cannula from damaging the guidewire.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
- If urine cannot be confirmed, STOP, determine fluoroscopic position and reintroduce assembled access 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