Background: The Barrx™ radiofrequency ablation (RFA) catheter system comes in several different variations and sizes and is widely used for the eradication of Barrett's esophagus (BE). The Barrx™ 360 and 360 Express system is used to perform circumferential RFA, while the Barrx™ focal catheter system is used for secondary focal RFA or primary treatment of short-segment BE. We aimed to investigate the number and type of complications and device failures associated with the Barrx™ RFA catheter system.
Method: We analyzed post-marketing surveillance data from the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from August 2011 to August 2021.
Results: During the study period, 148 unique reports detailing 78 device issues and 87 patient-related adverse events were identified. The most reported adverse events for patients were stenosis secondary to treatment (n=15, 17.24%), mucosal laceration of the esophagus (n=13, 14.94%), chest pain (n=10, 11.49%), and odynophagia/dysphagia (n=7, 8.05%). The most common device complication was failure of the device to deploy when activated (n=10, 13.82%). Other device malfunctions included material deformation/distortion (n=7, 8.97%), catheter breakage (n=6, 7.69%), connection problems between the generator cable and RFA device (n=6, 7.69%), and failure of the balloon to properly inflate (n=5, 6.41%).
Conclusion: Findings from the MAUDE database highlight patient and device complications that endoscopists should be aware of prior to RFA of BE with the Barrx™ RFA catheter system.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9210780 | PMC |
| http://dx.doi.org/10.20524/aog.2022.0721 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
The BEnefit of LONGitudinal Micro-Incisions Prior to Paclitaxel-Coated Balloon Angioplasty (BELONG Study) in Patients With Lower Extremity Arterial Disease: Clinical Outcomes at 12 Months.
J Endovasc Ther
January 2025
Angiology, HFR Fribourg, Hôpital Universitaire et Cantonal, Fribourg, Switzerland.
Purpose: Angioplasty of lower extremity arteries with calcification may result in flow-limiting dissection requiring bail-out stenting with unfavorable long-term outcomes. Vessel preparation prior to angioplasty may improve immediate results of the angioplasty and long-term patency. This prospective study assessed the 12-month outcomes of patients who underwent novel vessel preparation catheter, the FLEX Vessel Prep™ System (FLEX VP), prior to drug-coated balloon angioplasty (DCB-PTA).
View Article and Find Full Text PDFComparison of failure rates between full-barium and striped barium distal shunt catheters: a matched case-control study.
Childs Nerv Syst
January 2025
Department of Neurosurgery, Division of Pediatric Neurosurgery, University of Alabama at Birmingham, Children's of Alabama, 1600 7th Avenue South, Lowder 400, Birmingham, AL, 35233, USA.
Purpose: We hypothesize that distal shunt catheters fully impregnated with barium are more prone to failure compared to distal catheters with only a barium stripe. We sought to evaluate this distinction using a matched case-control study.
Methods: Patient records over an 8-year period were queried for distal shunt revisions for fracture or disconnection (cases).
The utility of routine intraoperative CSF during ventricular shunt insertion: a 10-year retrospective cohort study.
J Neurosurg Pediatr
January 2025
1Department of Neurosurgery, Queensland Children's Hospital, Brisbane; and.
Objective: Ventricular shunt insertion is a common procedure in pediatric neurosurgical practice. In many areas of medicine there is a push toward rationalization of healthcare resources and a reduction in low-value tests or procedures. The intraoperative sampling of CSF at the time of shunt insertion is one traditional aspect of care that has not been rigorously evaluated.
View Article and Find Full Text PDFRetrospective evaluation of a novel ultrasound-based imaging analysis software for predicting radiofrequency ablation areas.
PLoS One
January 2025
Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Objective: This study aimed to introduce and evaluate a novel software-based system, BioTrace, designed for real-time monitoring of thermal ablation tissue damage during image-guided radiofrequency ablation for hepatocellular carcinoma (HCC).
Methods: BioTrace utilizes a proprietary algorithm to analyze the temporo-spatial behavior of thermal gas bubble activity during ablation, as seen in conventional B-mode ultrasound imaging. Its predictive accuracy was assessed by comparing the ablation zones it predicted with those annotated by radiologists using contrast-enhanced computed tomography (CECT) 24 hours post-treatment, considered the gold standard.
Novel Use of a Catheter-Based Device Retrieval System for Percutaneous Treatment of Recurrent Atrial Myxoma.
JACC Case Rep
January 2025
Department of Cardiology, Kaiser Permanente Downey Medical Center, Downey, California, USA.
Surgical resection is standard of care for the treatment of atrial myxoma. However, the optimal management strategy for recurrent cardiac tumors is less clear. Here we report the novel use of a catheter-based device retrieval system for the removal of a recurrent cardiac myxoma.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!