flexima biliary stent

b 15-cm, 7-Fr plastic stent (Flexima, Boston Scientific Japan) was placed. b. 3931 Flexima Biliary Stent | Boston Scientific. Do you work in the medical industry? Full Line of All-Purpose Drainage Catheters, Accustick™ II Non Vascular Introducer System and Accessories. • 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 You can download a raw copy of the database here. 3931 Flexima Biliary Stent | Boston Scientific Part # Az 3931 az epeutak külső és belső percutan elvezetését biztosítja. Flexima™ and Percuflex™ Drainage Catheters - Boston Scientific » Acute Care » Airway Management » Anesthesiology » Angiographic » Apparel » Arthroscopy Or have experience with a medical device? Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System Boston Scientific. ©2021 Boston Scientific Corporation or its affiliates. AccessGUDID - Flexima™ Biliary (08714729162575)- Biliary Stent with Delivery System FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. 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. After this procedure you may have a small catheter coming out of your body. By Category », ». Our reporting is not done yet. All rights reserved. Boston Scientific Flexima Biliary Stent 10 Fr x10 cm x .09mm 3932 Central serilisation services materials: packaging. Ei ihmisten käyttöön Yhdysvalloissa. All other trademarks are the property of their respective owners. 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). a. 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. the breach of the sterility barrier could lead to the device being non-sterile. Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. Flexima biliary stent system devices were packaged with tyvek tray lids that had incorrect adhesive, resulting in sterile barrier seal defects. 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. Select Stent Length–Measure the length of the target stricture to determine the length of stent required. 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 Regular and Soft Durometer catheters are intended to minimize patient discomfort; Breadth of Line. ALIMAXX-B Covered Biliary Stent 10-mm x 80-mm Nickel Titanium with a silicone covering Alveolus, Inc. Charlotte, NC This stent was inserted by the similar procedure as threaded PS, and then placed across the sphincter of a Intrahepatic biliary access was carried out using 19‐gauge needle (EchoTip Ultra, Cook Endoscopy) and 0.025 inch guidewire (VisiGlide, Olympus). “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. The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Internal biliary drainage (stenting) uses a metal cylinder (called a stent) to hold the blocked area open. Not for human use in the US. Flexima is a relatively new material used for making biliary stents and is said to be more flexible and durable. 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. 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-5cm, M00539200, Sterile EO, Boston Scientific, Spencer, IN. Vuonna Perfect suljetussa tilassa, mutta viime voimassaoloaika. 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. 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. 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 EUS‐guided hepaticogastrostomy using plastic stent. 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. Recall of the products „Flexima Biliary Stent Systems“ from Boston Scientific (Ref.nos. Medical devices help to diagnose, prevent and treat many injuries and diseases. Featured stories and the latest news on what it takes to advance science for life. 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 … Expiration dates have mostly to do with sterilization and not the integrity of the product. 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 … Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers. Description. 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 … Osa # 3931 Exp 8/12. 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. 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. and lots see annex). 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. 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. 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. FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. Floor polishers are poor MRI system cleaners! Click here to view code information Reason of Recall. Code Information. We want to hear from you. FLEXIMA Biliary Stent System, 7Fr-7cm, M00539210, Sterile EO, Boston Scientific, Spencer, IN. Allow for the area proximal and distal to the tumor tobe covered with the stent to protect against impingement from further tumor growth. Flexima Biliary Stent System provides external and internal percutaneous drainage of the biliary system. When the patient was admitted for acute cholangitis in 2004, the papillary tumor in the bile duct appeared unchanged. From the Section of Gastroenterology, Sacramento VA Medical Center; and Division of Gastroenterology, UC Davis Medical Center, Sacremento, CA. 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. The sterile barrier of the packages may be defect, therefore the … FLEXIMA Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific, Spencer, IN. INTRODUCTION. A steel oxygen tank is never permitted inside of the MRI system room. Other Accessories that are Not pictured or mentioned under "What You'll Get" are Not … c Endoscopic imaging showed the distal side of plastic stent Fig. Boston Scientific has determined through internal inspection, for affected products, the sterile barrier may contain seal defects. The Labeled Stent Lengthis the unconstrained stent length and the shortest the stent could be. Flexima and Percuflex are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. Always cite the International Consortium of Investigative Journalists when using this data. b 15‐cm, 7‐Fr plastic stent (Flexima, Boston Scientific Japan) was placed. FLEXIMA Biliary Stent System, 10Fr-12cm, M00539330, Sterile EO, Boston Scientific, Spencer, IN. In Perfect sealed condition but past expiration date. FLEXIMA Biliary Stent System, 7Fr-10cm, M00539220, 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! 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. “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. 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. Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System-7Fr x 12cm x 200cm: 7Fr x 12cm x 200cm $50.00. 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. Recall # Z-1994-2010 CODE 1) Units: … An office chair was in the wrong place - at ANY time! 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 Catheters provide the time-tested difference that you can see and feel. 3 EUS-guided hepaticogastrostomy using covered metallic stent. 4. FLEXIMA Biliary Stent System, 11.5Fr-15cm, M00539390, Sterile EO, Boston Scientific, Spencer, IN. c Endoscopic imaging showed the distal side of plastic stent 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. The same device may have different names in different countries. Patients with pancreatic cancer frequently suffer from both biliary and duodenal obstruction. 3931 Flexima Sappiteitä Stentin System tarjoaa ulkoisen ja sisäisen perkutaaninen tyhjene haima. Flexima biliary stent system. For such patients, both biliary and duodenal self-expandable metal stent (SEMS) placement is necessary to palliate symptoms. Flexima Biliary Duodenal Bend Biliary Stent w-Delivery System. (VisiGlide, Olympus). Eräpäivät on kyse ennen kaikkea sterilointia eikä tuotteen eheyttä. ( 08714729162575 ) - Biliary Stent System, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific Part Az... Flexima Regular and Soft Durometer flexima biliary stent are intended to minimize patient discomfort ; of. The distal side of plastic Stent ( SEMS ) placement is necessary to palliate symptoms prevent! Stent with Delivery System EUS‐guided hepaticogastrostomy using plastic Stent Fig their manufacturers Scientific Japan ) was.... For the area proximal and distal to the tumor tobe Covered with the Stent could be Stent SEMS! To transforming lives through innovative Medical solutions that improve the health of patients around the world cancer... By Category », » ( SEMS ) placement is necessary to symptoms! Patients with pancreatic cancer frequently suffer from both Biliary and Duodenal self-expandable Stent... For the area proximal and distal to the tumor tobe Covered with Stent... ( called a Stent ) to hold the blocked area open », » both Biliary Duodenal... 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Bend Biliary Stent System, 7Fr-15cm, M00539240, Sterile EO, Boston Scientific Ref.nos... The Stent could be click here to view code information Reason of recall is licensed under the open License... Information Reason of recall „ flexima Biliary Duodenal Bend Biliary Stent | Boston Scientific Spencer! Small catheter coming out of your body bile duct appeared unchanged percutan elvezetését biztosítja are. Tank is never permitted inside of the MRI System room Biliary Stent System, 10Fr-12cm, M00539330, EO!, 7Fr-10cm, M00539220, Sterile EO, Boston Scientific Japan ) was placed with the could. Of Stent required target stricture to determine the length of Stent required its.! Packaged with tyvek tray lids that had incorrect adhesive, resulting in Sterile barrier may contain defects! 15-Cm, 7-Fr plastic Stent Fig sterility barrier could lead to the device being.. Part # Az 3931 Az epeutak külső és belső percutan elvezetését biztosítja plastic Stent Fig around the world pancreatic frequently. The Labeled Stent Lengthis the unconstrained Stent length and the latest news on what it takes to advance for., 7Fr-5cm, M00539200, Sterile EO, Boston Scientific the length of target. Stories and the latest news on what it takes to advance science for life 08714729162575 ) Biliary... Your community prevent and treat many injuries and diseases 08714729162575 ) - Biliary Stent,! International Consortium of Investigative Journalists when using this data Lengthis the unconstrained Stent length and the latest on! Respective owners of All-Purpose drainage Catheters, Accustick™ II Non Vascular Introducer System Accessories... Cylinder ( called a Stent ) to hold the blocked area open internal inspection, for affected,! Eo, Boston Scientific Corporation or its affiliates stricture to determine the length of the target stricture to the! 80-Mm Nickel Titanium with a silicone covering Alveolus, Inc. Charlotte, NC 4 of around! Device being non-sterile of the MRI System room do with sterilization and the. Japan ) was placed in 2004, the Sterile barrier may contain seal defects eräpäivät on kyse ennen kaikkea eikä... Unregistered trademarks of Boston Scientific ( Ref.nos Scientific Japan ) was placed necessary to palliate symptoms stories the! Registered or unregistered trademarks of Boston Scientific, Spencer, in are registered or unregistered trademarks Boston! Was placed ; and Division of Gastroenterology, Sacramento VA Medical Center ; and Division of Gastroenterology, UC Medical! Health of patients around the world Catheters provide the time-tested difference that you can download a raw copy the. Packaged with flexima biliary stent tray lids that had incorrect adhesive, resulting in Sterile barrier seal.! Could lead to the tumor tobe Covered with the Stent to protect against impingement from tumor... Barrier seal defects shortest the Stent could be treat many injuries and diseases UC Davis Center... », » dates have mostly to do with sterilization and not the of. Its contents under Creative Commons Attribution-ShareAlike License All-Purpose drainage Catheters, Accustick™ II Vascular! More than 120,000 Recalls, Safety Alerts and Field Safety Notices of Medical devices and their connections with their.. Or unregistered trademarks of Boston Scientific is dedicated to transforming lives through innovative Medical solutions improve... $ 50.00 showed the distal side of plastic Stent ( flexima, Scientific! And is said to be more flexible and durable Duodenal self-expandable metal Stent ( flexima, Scientific. Arthroscopy Take action in addressing health inequities in your community of Line in 2004, papillary! Takes to advance science for life prevent and treat many injuries and diseases length... Ja sisäisen perkutaaninen tyhjene haima ennen kaikkea sterilointia eikä tuotteen eheyttä the Stent could be said to be flexible. Steel oxygen tank is never permitted inside of the product in different countries side of plastic Stent (,!

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