C-22-05

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<h2>Indications, Safety, and Warnings</h2> <h3>Intended use</h3> <p>The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract. 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 Covidien directly.</li> <li>Store the device in a dry location with ambient conditions.</li> <li>Use of this device is restricted to trained healthcare professionals.</li> <li>When using a previously used SharkCore™ FNB needle (from the same procedure) or replacement needle of similar or different size, please go to step 19 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 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 SharkCore™ FNB needle should only be used in conjunction with the Beacon™ EUS delivery system.</li> </ul> <h3>Contraindications</h3> <ul> <li>Contraindications are those specific to primary endoscopic procedure to be performed in gaining access to desired site, including coagulopathy.</li> <li>Potential complications</li> <li>Potential complications associated with gastrointestinal endoscopy include, but are not limited to, perforation, hemorrhage, aspiration, fever, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, infection, allergic reaction to medication, damage to blood vessels, nerve damage, and acute pancreatitis.</li> <li>Potential complications associated with EU needle biopsy include, but are not limited to, bleeding, pain, death, peritonitis, infection/bacteremia, tumor seeding of the needle tract, and needle fracture requiring intervention for removal.</li> </ul> <h3>Precautions</h3> <ul> <li>Refer to package label for minimum endoscope channel size required to use this device.</li> <li>Needle must be retracted into sheath and thumbscrew on the 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>*Prior to Covidien’s acquisition of Beacon Endoscopic, this product was known as the BNX™ delivery system.</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 stylet is fully inserted when advancing the needle into the biopsy site. 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

The SharkCore™ FNB needle collects samples with intact cellular architecture.^1,–6 Its unique jaw-like profile and six distal cutting edges^1,4,7–11

Improve diagnostic yield^1–6,8
Collect cohesive units of tissue^1,4,7–11
Funnel samples into the lumen1^,4,7–11
Improve tissue access with a longer tip edge^{†,1,4,7–11}

Achieve consistent, predictable tissue acquisition with intact cellular architecture.^1–5

† Compared to FNA needle tips by decreasing penetration force.

Based on internal Beacon™ Endosopic report. REP-1085 (01) BNX EUS FNB Design Review. 2014.
Based on internal Beacon™ Endosopic report. REP-1090 (01) BNX EUS FNB Design Verification Review. 2014.
Adler DG, Witt B, Chadwick B, Wells J, Taylor LJ, Dimaio C, Schmidt R. Pathologic evaluation of a new endoscopic ultrasound needle designed to obtain core tissue samples: A pilot study. Endosc Ultrasound. 2016 May–Jun;5(3):178–183.
DiMaio CJ., et al. Initial Experience with a novel EUS-guided core biopsy needle (SharkCore™): results of a large North American multicenter study. Endosc Int Open. 2016 Sep;4(9): E974–E979.
Bang JY, Hebert-Magee S, Navaneethan U, Hasan MK, Hawes R, Varadarajulu S. Randomized trial comparing the Franseen and Fork-tip needles for EUS-guided fine-needle biopsy sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2018 Jun;87(6);1432–1438.
Kandel P, Tranesh G, Nassar A, Bingham R, Raimondo M, Woodward TA, Gomez V, Wallace MB. EUS-guided fine needle biopsy sampling using a novel fork-tip needle: a case-control study. Gastrointest Endosc. 2016 Dec;84(6):1034–1039.
Jovani M, Abidi WM, Lee LS. Novel fork-tip needles versus standard needles for EUS-guided tissue acquisition from solid masses of the upper GI tract: a matched cohort study. Scand J Gastroenterol. 2017;52(6-7):784–787.
Rodrigues-Pinto E, Jalaj S, Grimm IS, Baron TH. Impact of EUS-guided fine-needle biopsy sampling with a new core needle on the need for onsite cytopathologic assessment: a preliminary study. Gastrointest Endosc. 2016;84(6):1040–1046.
Moore JZ, McLaughlin PW, Shih AJ. Novel needle cutting edge geometry for end-cut biopsy. Med Phys. 2012;39(1):99–108.
Based on internal Covidien verification report. TR-20011 (1) SharkCore Design 2014.
Based on internal Covidien report. TR-20007 (1) EUS FNB Core Needle Comparative Test. 2014.

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