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 |