Evidence map›Paper›PMID 37084162›Full record

ArticleEsophagus : official journal of the Japan Esophageal Society2023

Patient adverse events and technical failures with the bravo capsule pH system: insights from the MAUDE database.

Daryl Ramai, Peter Bhandari, Anjali Kewalramani, Daniel Mozell, Saurabh Chandan, Antonio Facciorusso, Paraskevas Gkolfakis, Arun Swaminath, Douglas G Adler

Abstract read
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In one paragraph

Article in Esophagus : official journal of the Japan Esophageal Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Daryl RamaiDivision of Gastroenterology and Hepatology, University of Utah, Salt Lake City, UT, USA.
Peter BhandariDepartment of Internal Medicine, Northwell Health, Lenox Hill Hospital, New York, NY, USA.
Anjali KewalramaniDepartment of Internal Medicine, Mathers Hospital, Port Jefferson, NY, USA.
Daniel MozellDepartment of Internal Medicine, Elmhurst Hospital, Queens, NY, USA.
Saurabh ChandanDivision of Gastroenterology & Hepatology, CHI Health Creighton University Medical Center, Omaha, NE, USA.
Antonio FacciorussoSection of Gastroenterology, Department of Medical Sciences, University of Foggia, 71122, Foggia, Italy.
Paraskevas GkolfakisDepartment of Gastroenterology, Hepatopancreatology, and Digestive Oncology, CUB Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.
Arun SwaminathDivision of Gastroenterology, Northwell Health, Lenox Hill Hospital, New York, NY, USA.
Douglas G AdlerCenter for Advanced Therapeutic Endoscopy (CATE), Porter Adventist Hospital/PEAK Gastroenterology, Denver, CO, USA. dougraham2001@gmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe BRAVO pH monitor system can benefit patients with ongoing GERD symptoms despite treatment and/or atypical symptoms. We aim to investigate the number and type of complications associated with the BRAVO pH capsule.

methodsFrom April 2016 through February 2021, we analyzed post-marketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

resultsDuring the study period, approximately 1,651 reports were identified with 2391 cases associated with a device failure, and 254 reporting a patient-related adverse event. Most device complications were due to aspiration n = 153), followed by reported pain (n = 79), injury (unspecified) (n = 63), and additional radiologic imaging (n = 44). Laceration and bleeding accounted for 29 and 19 cases. Furthermore, three patients suffered perforation. Most device failures were due to loss or failure of the Bravo capsule to bond or adhere to the esophageal mucosa as planned (n = 1269), followed by an activation or positioning failure (n = 972), premature detachment of device (n = 284), and failure of the device to record or transmit data (n = 158).

conclusionsFindings from the MAUDE database highlight the risk of aspiration, hemorrhage/bleeding, perforation, injury, and retention as potential complications of BRAVO capsule placement.

Indexed as

HemorrhageHumansHydrogen-Ion ConcentrationNitrilesNitrilestetrachloroisophthalonitrileAdverse eventsBRAVOpH monitoringWireless device monitoring

Identifiers

PMID37084162

What OpenQuestion holds

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.