c Endoscopic imaging showed the distal side of plastic stent a Intrahepatic biliary access was carried out using 19‐gauge needle (EchoTip Ultra, Cook Endoscopy) and 0.025 inch guidewire (VisiGlide, Olympus). 3931 Flexima Sappiteitä Stentin System tarjoaa ulkoisen ja sisäisen perkutaaninen tyhjene haima. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. All rights reserved. In Perfect sealed condition but past expiration date. 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. Code Information. 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. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them. FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spencer, IN. EUS‐guided hepaticogastrostomy using plastic stent. Flexima and Percuflex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. 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. Full Line of All-Purpose Drainage Catheters, Accustick™ II Non Vascular Introducer System and Accessories. Description. • 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 When the patient was admitted for acute cholangitis in 2004, the papillary tumor in the bile duct appeared unchanged. and lots see annex). Recall of the products „Flexima Biliary Stent Systems“ from Boston Scientific (Ref.nos. 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 … Flexima Regular and Soft Durometer catheters are intended to minimize patient discomfort; Breadth of Line. A steel oxygen tank is never permitted inside of the MRI system room. 13132190, 13157130, 13187919, 13226335, 13250499, 13281255, 13122098, 13133678, 13139309, 13144163, 13150255, 13157375, 13164676, 13169430, 13172078, 13180899, 13197546, 13213768, 13220736, 13233454, 13251259, 13262950, 13278674, 13291033, 13293589, 13301698, 13306620, 13317116, 13326762, 13329148, 13332362, 13132880, 13142201, 13143356, 13143796, 13146820, 13153528, 13157508, 13165567, 13166306, 13169774, 13185696, 13186362, 13191710, 13200597, 13207924, 13217669, 13218935, 13227088, 13229799, 13234431, 13246627, 13258629, 13260101, 13263374, 13273999, 13285644, 13294293, 13300613, 13304567, 13310993, 13316305, 13320676, 13330228, 13331583, 13130923, 13147139, 13155258, 13172079, 13178809, 13191065, 13192581, 13200707, 13207118, 13210374, 13218941, 13231809, 13248449, 13254037, 13263744, 13271644, 13279829, 13282008, 13327106, Field Safety Notices about Flexima Biliary Stent System, International Consortium of Investigative Journalists. 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. Percuflex-Flexima Ureteral Stent INTENDED USE/INDICATIONS FOR USE The Ureteral Stent is intended to provide drainage from the ureteropelvic junction to the bladder and stenting of the ureter for all patients in whom it is desirable to place a drain which does not extend externally. AccessGUDID - Flexima™ Biliary (08714729162575)- Biliary Stent with Delivery System Double pigtail stents (7Fr or 8Fr, 5–10 cm, Cook Medical Inc., Bloomington, IN, USA) or Flexima stents (7Fr, 8.5Fr, or 10Fr, 5–10 cm, Boston Scientific) were selected at the surgeon’s discretion. » Acute Care » Airway Management » Anesthesiology » Angiographic » Apparel » Arthroscopy Flexima Biliary Stent System provides external and internal percutaneous drainage of the biliary system. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. Not for human use in the US. ©2021 Boston Scientific Corporation or its affiliates. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. 4. Flexima is a relatively new material used for making biliary stents and is said to be more flexible and durable. Featured stories and the latest news on what it takes to advance science for life. Flexima biliary stent system. Patients with pancreatic cancer frequently suffer from both biliary and duodenal obstruction. Allow for the area proximal and distal to the tumor tobe covered with the stent to protect against impingement from further tumor growth. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”, Injections / Infusions / Transfusions / Dialysis. “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. b 15-cm, 7-Fr plastic stent (Flexima, Boston Scientific Japan) was placed. This stent was inserted by the similar procedure as threaded PS, and then placed across the sphincter of INTRODUCTION. The Labeled Stent Lengthis the unconstrained stent length and the shortest the stent could be. b. Internal biliary drainage (stenting) uses a metal cylinder (called a stent) to hold the blocked area open. Select Stent Length–Measure the length of the target stricture to determine the length of stent required. Osa # 3931 Exp 8/12. 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. It was reported to boston scientific corporation that a flexima biliary stent was used during a stent placement procedure of the upper bile duct performed on (b)(6) 2012. All other trademarks are the property of their respective owners. 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 … b 15‐cm, 7‐Fr plastic stent (Flexima, Boston Scientific Japan) was placed. You can download a raw copy of the database here. (VisiGlide, Olympus). FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. 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. 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. 3931 Flexima Biliary Stent | Boston Scientific. Our reporting is not done yet. Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System. 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. Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific, Spencer, IN. 1: Add 3920-NE Boston Scientific Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System-7Fr x 5cm x 200cm-Non-Expired: 7Fr x 5cm x 200cm $100.00. Boston Scientific Flexima Biliary Stent 10 Fr x10 cm x .09mm 3932 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. a. Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System Boston Scientific. Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System-7Fr x 12cm x 200cm: 7Fr x 12cm x 200cm $50.00. 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 … Floor polishers are poor MRI system cleaners! Flexima Catheters provide the time-tested difference that you can see and feel. Other Accessories that are Not pictured or mentioned under "What You'll Get" are Not … FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. By Category », ». After this procedure you may have a small catheter coming out of your body. Expiration dates have mostly to do with sterilization and not the integrity of the product. Vuonna Perfect suljetussa tilassa, mutta viime voimassaoloaika. Plastic biliary stents ranging in length from 40 mm to 120 mm (Flexima, Boston Scientific, Marlborough, MA, USA) and SEM biliary stents ranging in length from 40 mm to 60 mm (WallFlex Uncovered, Boston Scientific, Marlborough, MA, USA) were deployed in the Elastic EHBD model with standard 8–10F catheters (N 6 per stent type). From the Section of Gastroenterology, Sacramento VA Medical Center; and Division of Gastroenterology, UC Davis Medical Center, Sacremento, CA. Do you work in the medical industry? 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. FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. M00539220: Boston Scientific Flexima Biliary Stent, Duodenal Bend 7F x 10cm Expired » Boston Scientific » Stents: Gastrointestinal Sign in to add this product to your favorites! Eräpäivät on kyse ennen kaikkea sterilointia eikä tuotteen eheyttä. Always cite the International Consortium of Investigative Journalists when using this data. Or have experience with a medical device? Ei ihmisten käyttöön Yhdysvalloissa. FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer, IN. The same device may have different names in different countries. c Endoscopic imaging showed the distal side of plastic stent Fig. Central serilisation services materials: packaging. Medical devices help to diagnose, prevent and treat many injuries and diseases. 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. Take action in addressing health inequities in your community. Flexima™ and Percuflex™ Drainage Catheters - Boston Scientific Recall # Z-1994-2010 CODE 1) Units: … The sterile barrier of the packages may be defect, therefore the … Full Line of All Purpose Drainage Catheters in J-tip and locking loop pigtail configurations; Biliary Drainage Catheters; Nephrostomy Drainage Catheters; Ureteral Stents; Nephrourteral Stents Click here to view code information Reason of Recall. 3931 Flexima Biliary Stent | Boston Scientific Part # Az 3931 az epeutak külső és belső percutan elvezetését biztosítja. Boston Scientific has determined through internal inspection, for affected products, the sterile barrier may contain seal defects. 3 EUS-guided hepaticogastrostomy using covered metallic stent. An office chair was in the wrong place - at ANY time! FLEXIMA Biliary Stent System, 7Fr-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, IN. the breach of the sterility barrier could lead to the device being non-sterile. For such patients, both biliary and duodenal self-expandable metal stent (SEMS) placement is necessary to palliate symptoms. 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 … Flexima biliary stent system devices were packaged with tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. We want to hear from you.

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