DSF-22-01

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<h2>Indications, Safety, and Warnings</h2> <h3>Intended use</h3> <p>The device is intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle stick injury.</p> <h3>Notes</h3> <ul> <li>If package is opened or damaged when received, do not use. Visually inspect the device for damage, kinks, bends, or breaks. If an abnormality is detected which could interfere with appropriate device use, do not use the device. Please notify your Medtronic sales representative or contact Medtronic directly.</li> <li>Store the device in a dry location at ambient conditions.</li> <li>Use of this device is restricted to trained healthcare professionals.</li> <li>When using a replacement fiducial needle of similar or different size, please go to step 16 of the instructions for use section.</li> </ul> <h3>Warnings</h3> <ul> <li>Do not use this device for any purpose other than the stated intended use.</li> <li>This product is supplied sterile and is intended for single use only. Do not re-sterilize, re-load fiducials, or re-use. It has not been designed to be re-used/re-sterilized. Reprocessing may lead to changes in material characteristics which may impact the strength of the device and compromise device performance. Re-use of single-use devices can also cause cross-contamination leading to patient infection. These risks may potentially affect patient safety. After use, dispose of product and packaging per institutional guidelines for biohazardous medical waste.</li> <li>The Beacon™ FNF needle should only be used in conjunction with the Beacon™ EUS delivery system.</li> </ul> <h3>Contraindications</h3> <p>The contraindication specific to primary endoscopic procedures to be performed in gaining access to the desired fiducial implantation site includes coagulopathy.</p> <h3>Potential complications</h3> <p>Potential complications associated with gastrointestinal endoscopy include, but are not limited to, perforation, hemorrhage, aspiration, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, infection/fever, bacteremia, allergic reaction to medication, damage to blood vessels, nerve damage, tumor seeding of the needle tract and acute pancreatitis.</p> <p>Potential complications associated with EUS fiducial placement include, but are not limited to, improper fiducial placement, fiducial migration, infection/fever, allergic reaction, local inflammatory foreign body response, minor bleeds, pain, pancreatitis, and needle fracture requiring intervention for removal.</p> <h3>Precautions</h3> <ul> <li>Refer to package label for minimum endoscope channel size required to use this device.</li> <li>*Prior to Covidien’s acquisition of Beacon Endoscopic, this product was known as the BNX™ delivery system.</li> <li>Needle must be retracted into sheath and thumbscrew on locking safety ring must be securely locked to hold needle in place prior to introduction, advancement, or withdrawal of the device or introduction, advancement, or withdrawal of the needle during needle exchange. Failure to retract the needle may result in damage to the endoscope.</li> <li>When removing needle from package, ensure that the needle sheath is locked in place on the needle and the sheath covers the end of the needle. If the needle sheath is not locked into place on the needle, user injury may result.</li> <li>Ensure that the deployment indicator is securely locked onto the needle luer at the home position. If the stylet has been advanced beyond the home position, the fiducials may have been inadvertently deployed. In this event, disregard the device and open a new device.</li> <li>Ensure that the needle hub is securely locked in the handle of the device prior to using the device. Failure to ensure that needle hub is securely locked in the handle of the device prior to use may result in damage to the endoscope or user injury.</li> </ul>

Description

Simplify your endoscopic ultrasound (EUS) procedures with a single solution.

The Beacon™ FNF system’s exchangeable design and two pre-loaded fiducial markers allow you to facilitate tissue sampling and fiducial placement in the same procedure¹— eliminating manual fiducial loading,² reducing overall procedure time³, and lessening potential needle stick exposure for staff.⁴

Choi JH, Seo DW, Park DH, Lee SK, Kim MH. Fiducial placement for stereotactic body radiation therapy under only endoscopic ultrasonography guidance in pancreatic and hepatic malignancy: practical feasibility and safety. Gut Liver. 2014;8(1):88–93. doi:10.5009/gnl.2014.8.1.88.
TR-20015 (01) Design Verification Report - FNF. Covidien; 2015.
Kothari S, Kothari T, Wang G, Gonda TA, Gress FG, Kaul V. EUS-guided fiducial placement for stereotactic body radiotherapy (SBRT): first global experience with a new 22-gauge ‘pre-loaded’ EUS fiducial needle. Am J Gastroenterol. 2015;110(Suppl 1):S102.
TR-20018 (01) Design Verification Report - FNF. Covidien; 2015.

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