MedStar Authors catalog › Details for: Adverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database.
Citation: ; Cardiovascular Revascularization Medicine. 20(5):409-412, 2019 05..Journal: Cardiovascular revascularization medicine : including molecular interventions.Published: ; 2019; ISSN: 1878-0938.Full author list: Bernardo NL; Chen Y; Gajanana D; Hashim H; Iantorno M; Khalid N; Khan JM; Musallam A; Rogers T; Shah AA; Shlofmitz E; Waksman R.UI/PMID: 31079818.Subject(s): *Cardiac Catheters/ae [Adverse Effects] | United States Food and Drug Administration | United States | Treatment Outcome | Risk Factors | Risk Assessment | *Product Surveillance, Postmarketing | Percutaneous Coronary Intervention/mo [Mortality] | *Percutaneous Coronary Intervention/is [Instrumentation] | *Percutaneous Coronary Intervention/ae [Adverse Effects] | Humans | Equipment Failure | Equipment Design | Databases, Factual | *Coronary Artery Disease/th [Therapy] | Coronary Artery Disease/mo [Mortality] | Coronary Artery Disease/dg [Diagnostic Imaging]Institution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal ArticleOnline resources: Click here to access onlineDigital Object Identifier: https://dx.doi.org/10.1016/j.carrev.2019.02.016 (Click here)Abbreviated citation: ; Cardiovasc Revasc Med. 20(5):409-412, 2019 05.Local Holdings: Available in print through MWHC library: 2002 - present.Abstract: BACKGROUND/PURPOSE: We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters.Abstract: CONCLUSIONS: Findings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters.Abstract: Copyright (c) 2019 Elsevier Inc. All rights reserved.Abstract: METHODS/MATERIALS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events.Abstract: RESULTS: 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. 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.Abstract: SUMMARY: 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. There were more reports on Guidezilla-related events during the search period. 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.