![]() The events for both extension catheters mainly involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the extension catheter, extension catheter fracture, coronary artery dissection and perforation and, occasionally, the death of the patients.Ĭomplications Guide extension catheter Percutaneous coronary intervention.Ĭopyright © 2019 Elsevier Inc. The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). 0.001'' Smaller O.D.1 0.057 (1.45 mm) Inner-diameter allows more room to deliver interventional devices. ![]() There were more reports on Guidezilla-related events during the search period. 1x1 Braid provides extra back-up support without over-straightening the vessel 0.001'' Larger I.D. Minimum digital size for BOTH our wordmark and logomark is 20 pixels. Do not stretch or distort Or as specific as: Our favicon must always be 16 x 16 pixels. Do not use our full logo unless there is ample space to allow for legibility. To assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters, the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried. Your minimum size and proportional value guideline could be as simple as: Should be legible at any size. Of the 408 cases with reported Guidezilla-related issues, 53 (13%) involved inability to pass or damaged PCI devices into the Guidezilla catheter, 117 (29%) involved inability to advance the Guidezilla catheter to the target lesion, 59 (14%) involved kinked Guidezilla catheter, mostly because of partial or complete catheter fracture upon further investigation, 164 (40%) involved a broken Guidezilla catheter, 10 (2.5%) involved coronary artery dissection, 2 (0.5%) involved coronary artery perforation, 1 (0.2%)involved aortic dissection, 1 (0.2%) involved thrombosis formation, and 1 (0.2%) involved no-reflow phenomenon.įindings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters. The purpose of this study was to assess the feasibility and safety of the usage of the GuideLiner (GL) catheter (Vascular Solutions Inc., Minneapolis, MN, USA) extension system in complex PCI of CTO. Of the 65 cases with reported GuideLiner-related issues, 15 (23%) involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the GuideLiner catheter, 38 (58%) involved GuideLiner catheter fracture, 9 (14%) involved coronary artery dissection, 2 (3%) involved coronary artery perforation, and 1 (1.5%) involved thrombus formation in the catheter. The Heartrail system (Terumo, Tokyo, Japan) is available in 5-Fr, 6-Fr, and, 7-Fr sizes . 6 GuideLiner V3 GEC measurements are from the product brochure. The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events. We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters.
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