Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database. (Record no. 4230)

MARC details
000 -LEADER
fixed length control field 04310nam a22007217a 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.2019.03.009 [doi]
024 ## - OTHER STANDARD IDENTIFIER
Standard number or code S1553-8389(19)30171-X [pii]
040 ## - CATALOGING SOURCE
Original cataloging agency Ovid MEDLINE(R)
099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC)
PMID 30962083
245 ## - TITLE STATEMENT
Title Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.
251 ## - Source
Source Cardiovascular Revascularization Medicine. 20(6):507-512, 2019 06.
252 ## - Abbreviated Source
Abbreviated source Cardiovasc Revasc Med. 20(6):507-512, 2019 06.
252 ## - Abbreviated Source
Former abbreviated source Cardiovasc Revasc Med. 2019 Mar 15
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 aheadofprint
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. 2019 Mar 15
501 ## - WITH NOTE
Local holdings Available in print through MWHC library: 2002 - present
520 ## - SUMMARY, ETC.
Abstract BACKGROUND/PURPOSE: Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use.
520 ## - SUMMARY, ETC.
Abstract CONCLUSIONS: Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use.
520 ## - SUMMARY, ETC.
Abstract Copyright (c) 2019 Elsevier Inc. All rights reserved.
520 ## - SUMMARY, ETC.
Abstract METHODS/MATERIALS: The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed.
520 ## - SUMMARY, ETC.
Abstract RESULTS: Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported.
546 ## - LANGUAGE NOTE
Language note English
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Cardiac Catheters
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 Vessels/dg [Diagnostic Imaging]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element *Tomography, Optical Coherence/is [Instrumentation]
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 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/is [Instrumentation]
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Predictive Value of Tests
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Retrospective Studies
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 Stents
650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Tomography, Optical Coherence/ae [Adverse Effects]
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
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Local Authors Chen, Yuefeng
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Local Authors Gallino, Robert
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Local Authors Garcia-Garcia, Hector M
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Local Authors Hashim, Hayder
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Iantorno, Micaela
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Kajita, Alexandre H
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 Rogers, Toby
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Shlofmitz, Evan
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Torguson, Rebecca
700 ## - ADDED ENTRY--PERSONAL NAME
Local Authors Waksman, Ron
790 ## - Authors
All authors Bernardo NL, Chen Y, Gallino RA, Garcia-Garcia HM, Hashim H, Iantorno M, Kajita AH, Khalid N, Khan JM, Rogers T, Shlofmitz E, Torguson R, Waksman R
856 ## - ELECTRONIC LOCATION AND ACCESS
DOI <a href="https://dx.doi.org/10.1016/j.carrev.2019.03.009">https://dx.doi.org/10.1016/j.carrev.2019.03.009</a>
Public note https://dx.doi.org/10.1016/j.carrev.2019.03.009
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   30962083 30962083 05/21/2019 05/21/2019 Journal Article

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