This year, Teleflex acquired two well-known PTCA balloon catheters. Each catheter configuration contains a specific design element to address various clinical challenges in complex procedures This portfolio consists of the Turnpike Catheter (standard version), the Turnpike Spiral Catheter, the Turnpike Gold Catheter, and the Turnpike LP Catheter. The unique five-layer composite shaft provides an ideal combination of flexibility and torque response to help navigate through complex anatomy while the outer polymer layer paired with a 60 cm distal hydrophilic coating facilitates smooth catheter delivery. These contain a robust multi-layer shaft that provides impressive flexibility, torque and tracking over a 0.014” guidewire in complex coronary and peripheral interventions. Teleflex also offers a family of Turnpike Catheters. Now in its third generation, the GuideLiner V3 Catheter continues to build on a history of innovation and performance - one that has been demonstrated with more than half a million catheters in cath labs around the world. 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.In 2009, the GuideLiner Catheter revolutionized the concept of guide extension, creating new possibilities in interventional cardiology. There were more reports on Guidezilla-related events during the search period.
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. 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. 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 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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