For such patients, both biliary and duodenal self-expandable metal stent (SEMS) placement is necessary to palliate symptoms. Or have experience with a medical device? FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. We want to hear from you. “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. EUS‐guided hepaticogastrostomy using plastic stent. Central serilisation services materials: packaging. FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, IN. Floor polishers are poor MRI system cleaners! c Endoscopic imaging showed the distal side of plastic stent If you have a catheter, you will return to Interventional Radiology later the same day or the following day so your doctor can see if the stent is working well. FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a … By Category », ». The same device may have different names in different countries. Flexima Regular and Soft Durometer catheters are intended to minimize patient discomfort; Breadth of Line. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spencer, IN. 3931 Flexima Biliary Stent | Boston Scientific. the breach of the sterility barrier could lead to the device being non-sterile. An office chair was in the wrong place - at ANY time! b. Take action in addressing health inequities in your community. The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Expiration dates have mostly to do with sterilization and not the integrity of the product. All other trademarks are the property of their respective owners. c Endoscopic imaging showed the distal side of plastic stent Fig. Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System Boston Scientific. Flexima is a relatively new material used for making biliary stents and is said to be more flexible and durable. Flexima Biliary Stent System provides external and internal percutaneous drainage of the biliary system. Full Line of All-Purpose Drainage Catheters, Accustick™ II Non Vascular Introducer System and Accessories. Do you work in the medical industry? The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. The patient recovered well until she became symptomatic again in September 2007, for which an endoscopic retrograde biliary drainage (ERBD) catheter (FLEXIMA™ Biliary Stent System, Boston Scientific Co., Natick, MA, USA) was placed. FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. ©2021 Boston Scientific Corporation or its affiliates. Worldwide Distribution: United States and Puerto Rico, and countries of Arab Emirates, Argentina, Austria, Belgium, Canada, China, Columbia, Croatia, El Salvador, Estonia, Finland, France, Great Britain, Germany, Greece, Hungary, Iran, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, the Netherlands, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, and Uruguay. FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer, IN. All rights reserved. The Labeled Stent Lengthis the unconstrained stent length and the shortest the stent could be. Flexima biliary stent system devices were packaged with tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. Flexima biliary stent system. Boston Scientific has determined through internal inspection, for affected products, the sterile barrier may contain seal defects. a. When the patient was admitted for acute cholangitis in 2004, the papillary tumor in the bile duct appeared unchanged. a Intrahepatic biliary access was carried out using 19‐gauge needle (EchoTip Ultra, Cook Endoscopy) and 0.025 inch guidewire (VisiGlide, Olympus). Description. You can download a raw copy of the database here. • Flexima Catheter Firm Durometer is engineered to resist typical buckling forces encountered during percutaneous insertion • R/O Marker, on the Flexima Biliary Drainage Catheters with R/O, is intended to enhance visibility and accurate placement Drainage Ability Flexima Catheters are designed for excellent drainage performance 3931 Flexima Biliary Stent | Boston Scientific Part # Az 3931 az epeutak külső és belső percutan elvezetését biztosítja. In Perfect sealed condition but past expiration date. Flexima and Percuflex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. New BOSTON SCIENFITIC 3921 Flexima Biliary Stent System Disposables - General Um zu verkaufen - DOTmed Angebotseintrag #2391915: What You'll get: Boston Scientific 3921 Flexima Biliary Stent System 7Fr x 7cm Manual EXPIRED ON 02/2011 Anything Else Not Mentioned or Pictured NOT INCLUDED. After this procedure you may have a small catheter coming out of your body. Osa # 3931 Exp 8/12. Click here to view code information Reason of Recall. 3931 Flexima Sappiteitä Stentin System tarjoaa ulkoisen ja sisäisen perkutaaninen tyhjene haima. 3 EUS-guided hepaticogastrostomy using covered metallic stent. INTRODUCTION. Flexima™ and Percuflex™ Drainage Catheters - Boston Scientific ALIMAXX-B Covered Biliary Stent 10-mm x 80-mm Nickel Titanium with a silicone covering Alveolus, Inc. Charlotte, NC The Flexima Biliary Stent System is intended for delivery of the stent to the biliary tract for drainage of the bile ducts, for splinting of a bile duct during healing, or for providing bile duct patency in a stricture or past a stone. Always cite the International Consortium of Investigative Journalists when using this data. Select Stent Length–Measure the length of the target stricture to determine the length of stent required. Cardiac Resynchronization Therapy (CRT) Devices, Transcatheter Aortic Valve Replacement (TAVR), Medical Device ID Cards - Pacemaker, ICD, & CRT devices, Remote Patient Monitoring and Diagnostic Monitoring, Flexima™ and Percuflex™ Drainage Catheters, Boston Scientific Peripheral Interventions Product Catalog, ADVANTICS™ Innovative Healthcare Solutions, Introducer Systems, Sheaths, Fascial Dilators, Connector Tubes, Full Line of All Purpose Drainage Catheters in J-tip and locking loop pigtail configurations, Specialty Catheters including VanSonnenberg Sump Catheters, Temp Tip Catheters, Malecot Nephrostomy Catheters, and Amplatz Anchor™ Catheters. Always cite the International Medical devices and their connections with their manufacturers a Stent flexima biliary stent to hold the blocked open! Diagnose, prevent and treat many injuries and diseases of Medical devices Database is under... That had incorrect adhesive, resulting in Sterile barrier seal defects b 15-cm, 7-Fr Stent... 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