Pubfacts - Scientific Publication Data
  • Categories
  • Journals
  • ->
  • Login
  • Categories
  • Journals

Search Our Scientific Publications & Authors

Publications
  • Publications
  • Authors
find publications by category +
Translate page:
Get 20% Off Journals at LWW.com

Device-Related Adverse Events During Percutaneous Nephrolithotomy: Review of the Manufacturer and User Facility Device Experience Database.

Authors:
Neel H Patel Ariel A Schulman Jonathan B Bloom Nikil Uppaluri John L Phillips Sensuke Konno Muhammad Choudhury Majid Eshghi

J Endourol 2017 10;31(10):1007-1011

1 Department of Urology, New York Medical College , Valhalla, New York.

Introduction And Objectives: Percutaneous nephrolithotomy (PCNL) is an established technique for removal of large stones from the upper urinary tract. It is a complex multistep procedure requiring several classes of instruments that are subject to operator misuse and device malfunction. We report device-related adverse events during PCNL from the Manufacturer and User Facility Device Experience (MAUDE) database using a recently developed standardized classification system.

Materials And Methods: The MAUDE database was queried for "percutaneous nephrolithotomy" from 2006 to 2016. The circumstances and patient complications associated with classes of devices used during PCNL were identified. We then utilized a novel MAUDE classification system to categorize clinical events. Logistic regression analysis was performed to identify associations between device classes and severe adverse events.

Results: A total of 218 device-related events were reported. The most common classes included: lithotripter 53 (24.3%), wires 43 (19.7%), balloon dilators 30 (13.8%), and occlusion balloons 28 (12.8%). Reported patient complications included need for a second procedure 12 (28.6%), bleeding 8 (19.0%), retained fragments 7 (16.7%), prolonged procedure 4 (9.5%), ureteral injury 2 (4.8%), and conversion to an open procedure 3 (7.1%). Using a MAUDE classification system, 176 complications (81%) were Level I (mild/none), 26 (12%) were Level II (moderate), 15 (7%) were Level III (severe), and 1 (0.5%) was Level IV (life threatening). On univariate analysis, balloon dilators had the highest risk of Level II-IV complications compared with the other device classes [odds ratio: 4.33, confidence interval: 1.978, 9.493, p < 0.001]. The device was evaluated by the manufacturer in 93 (42.7%) cases, with 54.8% of reviewed cases listing the source of malfunction as misuse by the operator.

Conclusions: PCNL is subject to a wide range of device-related adverse events. A MAUDE classification system is useful for standardized, clinically-relevant reporting of events. Our findings highlight the importance of proper surgeon training with devices to maximize efficiency and decrease harm.

Download full-text PDF

Source
http://dx.doi.org/10.1089/end.2017.0343DOI Listing
October 2017

Publication Analysis

Top Keywords

device experience
8
facility device
8
user facility
8
maude classification
8
maude database
8
device classes
8
balloon dilators
8
manufacturer user
8
classification system
8
adverse events
8
device-related adverse
8
patient complications
8
percutaneous nephrolithotomy
8
level
5
classes
5
device
5
logistic regression
4
performed identify
4
threatening univariate
4
level iii
4

Similar Publications

First Pass Recanalization Rates of Solitaire vs Trevo vs Primary Aspiration: The Kaiser Southern California Experience.

Authors:
Conrad W Liang Harjyot J Toor Evelin Duran Martinez Sunil A Sheth Kuo Chao Lei Feng Mazen Noufal Binh V Nguyen Pankaj J Mowji Navdeep Sangha

Perm J 2020 Dec;25:1-3

Department of Neurology, Los Angeles Medical Center, Los Angeles, CA.

Context: New stroke thrombectomy devices have significantly improved recanalization rates in patients with large vessel occlusion. The first pass effect, or complete or near complete recanalization after a single pass of a device, is associated with better outcome. However, it remains unclear whether one technique is superior to the others at first pass recanalization. Read More

View Article and Full-Text PDF
December 2020
Similar Publications

Acute heart transplantation from mechanical circulatory support in a human immunodeficiency virus-positive patient with fulminant myocarditis.

Authors:
Zsofia Szakal-Toth Janos Szlavik Adam Soltesz Viktor Berzsenyi Gergely Csikos Tamas Varga Kristof Racz Akos Kiraly Balazs Sax Istvan Hartyanszky Attila Fintha Zoltan Prohaszka Katalin Monostory Bela Merkely Endre Nemeth

ESC Heart Fail 2021 Feb 25. Epub 2021 Feb 25.

Department of Anaesthesiology and Intensive Therapy, Semmelweis University, Budapest, Hungary.

Since the establishment of highly active antiretroviral therapy, survival rates have improved among patients with human immunodeficiency virus infection giving them the possibility to become transplant candidates. Recent publications revealed that human immunodeficiency virus-positive heart transplant recipients' survival is similar to non-infected patients. We present the case of a 40-year-old human immunodeficiency virus infected patient, who was hospitalized due to severely decreased left ventricular function with a possible aetiology of acute myocarditis, that has later been confirmed by histological investigation of myocardial biopsy. Read More

View Article and Full-Text PDF
February 2021
Similar Publications

Speech Perception and Language Outcomes for Infants Receiving Cochlear Implants Before or After 9 Months of Age: Use of Category-Based Aggregation of Data in an Unselected Pediatric Cohort.

Authors:
Shani Dettman Dawn Choo Agnes Au Amy Luu Richard Dowell

J Speech Lang Hear Res 2021 Feb 25:1-17. Epub 2021 Feb 25.

Department of Audiology and Speech Pathology, The University of Melbourne, Parkville, Victoria, Australia.

Purpose This retrospective study aimed to amass large data sets to enable statistical comparisons of communication outcomes for infants receiving cochlear implants (CIs) before 9 months of age compared to groups who received their first CI between 9 months and 3.5 years of age. Method Speech perception scores and experienced clinicians' observations were used to refine the Categories of Auditory Performance Index (CAPI), thus creating its revised version, namely, the CAPI-Revised (CAPI-R). Read More

View Article and Full-Text PDF
February 2021
Similar Publications

Clinical profile and midterm prognosis of left ventricular thrombus in heart failure.

Authors:
Anne-Iris Lemaître François Picard Vincent Maurin Maxime Faure Pierre Dos Santos Nicolas Girerd

ESC Heart Fail 2021 Feb 25. Epub 2021 Feb 25.

Université de Lorraine, Inserm, Centre d'Investigations Cliniques Plurithématique 1433, Inserm U1116, CHRU Nancy, and F-CRIN INI-CRCT (Cardiovascular and Renal Clinical Trialists), Nancy, France.

Aims: We documented the midterm prognosis of left ventricular thrombus (LVT) in heart failure (HF) patients with dilated cardiomyopathy (DCM) and ischaemic cardiomyopathy (ICM). We aimed to characterize patients with LVT in the context of HF with reduced (≤40%) left ventricular ejection fraction and evaluate their risk for death and/or embolic events, overall, and specifically in patients with ischaemic or non-ischaemic aetiology. We also intended to identify risk factors for LVT in patients with DCM. Read More

View Article and Full-Text PDF
February 2021
Similar Publications

Viscoelastic Coagulation Monitor as a Novel Device to Assess Coagulation at the Bedside. A Single-Center Experience During the COVID-19 Pandemic.

Authors:
Mauro Panigada Andrea Meli Eleonora Scotti Paolo Properzi Matteo Brioni Shady Kamel Stefano Ghirardello Luigia Scudeller Heidi J Dalton Giacomo Grasselli

ASAIO J 2021 03;67(3):254-262

From the Department of Anaesthesia and Critical Care, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.

Viscoelastic coagulation monitor (VCM) is a portable device developed to evaluate the viscoelastic properties of whole blood activated by contact with glass. In this study, VCM was employed to analyze the viscoelastic profiles of 36 COVID-19 intensive care patients. Full anticoagulant dose heparin (unfractionated [UFH]; low molecular weight [LMWH]) was administrated to all patients. Read More

View Article and Full-Text PDF
March 2021
Similar Publications
Get 20% Off Journals at LWW.com
© 2021 PubFacts.
  • About PubFacts
  • Privacy Policy
  • Sitemap