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https://www.penumbrainc.com/neuro-device/neuron-system/
The Neuron ® Intracranial Access System allows for rapid distal placement into the neurovasculature, providing both robust intracranial support and a wide range of device compatibility.. Penumbra Select ™ Catheters enable Rapid Primary Access into final position, …
https://www.penumbrainc.com/neuro-device/distal-delivery-catheters/
The Penumbra 5MAX™ and 4MAX™ Distal Delivery Catheters (DDC) are designed to simplify therapy delivery to the most distal, tortuous anatomy. The tapered inner shaft maximizes the effective flow lumen to facilitate exceptional angiographic roadmapping. These catheters are offered in three lengths, enabling a wide variety of device compatibility.
https://www.accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1588990
The 070 neuron was utilized to deliver coils to an acomm aneurysm. The micro catheter and coils were successfully delivered to the treatment site with little to no guide catheter movement during the entire case. Upon removing the neuron from the pt and inspection of the catheter, a slight kink was noticed approx 5cm from the distal tip.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2143998
As the neuron was pulled back by the proximal end, a crack developed near the hub where the yellow jacket sits over the catheter. The physician removed a second neuron from his inventory to complete the procedure. During removal of the second neuron, the physician adjusted his hands more distal to the hub.
https://sfda.gov.sa/en/medicaldevices/recalls/RecallPages/Pages/6-F1)PenumbraNeuronDeliveryCatheter070.aspx
Penumbra Neuron Delivery Catheter 070. Description. Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by . Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature ...
https://www.healthcarepackaging.com/issues/regulatory/press-release/13281543/neuron-6f-070-delivery-catheter
Penumbra and FDA notified healthcare professionals about a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter.
https://www.aboutlawsuits.com/penumbra-catheters-recall-neuron-6f-070-delivery-catheter-6238/
Oct 02, 2009 · Older versions of Penumbra Inc.’s Neuron 6F 070 Delivery Catheter have been recalled in the wake of reports that some catheters have kinked, ovalized or broken, resulting in injuries. The Penum
https://www.biospace.com/article/releases/penumbra-inc-announces-worldwide-voluntary-field-removal-of-the-original-version-of-6f-neuron-070-delivery-catheter-/
Sep 30, 2009 · Penumbra, Inc. Announces Worldwide Voluntary Field Removal of the Original Version of 6F Neuron 070 Delivery Catheter - read this article along with …
https://www.yourlawyer.com/defective-medical-devices/recalls/penumbra-recalls-neuron-catheter/
Oct 01, 2009 · Original Version of Penumbra.Penumbra is initiating a voluntary Field Removal of the original version of its Neuron 6F 070 Delivery Catheter, the U.S. Food and Drug Administration (FDA) just announced. Penumbra has received feedback from some users that these recalled catheters could kink or ovalize in certain anatomical situations.. This kinking and/or ovalization of the catheter lumen can ...
https://evtoday.com/articles/2016-feb/penumbra-system-for-intracranial-mechanical-thrombectomy
The inflated balloon and its associated catheter were used to anchor the system, allowing for delivery of the Neuron MAX 088 device into the common carotid artery. A 5MAX ACE catheter was delivered to the occlusion site over a Velocity® microcatheter (Penumbra, Inc.) and a 0.014-inch Synchro2 wire. The clot was engaged at 1:35 PM.
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