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. (Record no. 4237)

MARC details
000 -LEADER
fixed length control field 04899nam a22007337a 4500
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 190521s20192019 xxu||||| |||| 00| 0 eng d
022 ## - INTERNATIONAL STANDARD SERIAL NUMBER
International Standard Serial Number 1878-0938
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code 10.1016/j.carrev.2019.02.016 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S1553-8389(19)30149-6 [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 31079818
245 ## - TITLE STATEMENT
Title 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.
251 ## - Source
Source Cardiovascular Revascularization Medicine. 20(5):409-412, 2019 05.
252 ## - Abbreviated Source
Abbreviated source Cardiovasc Revasc Med. 20(5):409-412, 2019 05.
252 ## - Abbreviated Source
Former abbreviated source Cardiovasc Revasc Med. 20(5):409-412, 2019 May.
253 ## - Journal Name
Journal name Cardiovascular revascularization medicine : including molecular interventions
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Year 2019
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Manufacturer FY2019
265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE]
Publication status ppublish
266 ## - Date added to catalog
Date added to catalog 2019-05-21
268 ## - Previous citation
-- Cardiovascular Revascularization Medicine. 20(5):409-412, 2019 May.
501 ## - WITH NOTE
Local holdings Available in print through MWHC library: 2002 - present
520 ## - SUMMARY, ETC.
Abstract BACKGROUND/PURPOSE: We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters.
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: Findings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters.
520 ## - SUMMARY, ETC.
Abstract Copyright (c) 2019 Elsevier Inc. All rights reserved.
520 ## - SUMMARY, ETC.
Abstract METHODS/MATERIALS: The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events.
520 ## - SUMMARY, ETC.
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.
520 ## - SUMMARY, ETC.
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.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Cardiac Catheters/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Coronary Artery Disease/th [Therapy]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Percutaneous Coronary Intervention/ae [Adverse Effects]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Percutaneous Coronary Intervention/is [Instrumentation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Product Surveillance, Postmarketing
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coronary Artery Disease/dg [Diagnostic Imaging]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Coronary Artery Disease/mo [Mortality]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Databases, Factual
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Equipment Design
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Equipment Failure
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Humans
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Percutaneous Coronary Intervention/mo [Mortality]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Risk Assessment
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Risk Factors
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Treatment Outcome
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element United States Food and Drug Administration
651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME
Institution MedStar Heart & Vascular Institute
657 ## - INDEX TERM--FUNCTION
Medline publication type Journal Article
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Bernardo, Nelson L
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Chen, Yuefeng
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Gajanana, Deepakraj
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Hashim, Hayder
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Iantorno, Micaela
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Khalid, Nauman
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Khan, Jaffar M
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Musallam, Anees
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Rogers, Toby
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Shah, Arhum A
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Shlofmitz, Evan
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
790 ## - Authors
All authors Bernardo NL, Chen Y, Gajanana D, Hashim H, Iantorno M, Khalid N, Khan JM, Musallam A, Rogers T, Shah AA, Shlofmitz E, Waksman R
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1016/j.carrev.2019.02.016">https://dx.doi.org/10.1016/j.carrev.2019.02.016</a>
Public note https://dx.doi.org/10.1016/j.carrev.2019.02.016
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Journal Article
Item type description Article
Holdings
Withdrawn status Lost status Damaged status Not for loan Collection Home library Current library Date acquired Total Checkouts Full call number Barcode Date last seen Price effective from Koha item type
          MedStar Authors Catalog MedStar Authors Catalog 05/21/2019   31079818 31079818 05/21/2019 05/21/2019 Journal Article

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