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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP BARRX UNKNOWN BARRX 360; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

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COVIDIEN LP BARRX UNKNOWN BARRX 360; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES Back to Search Results
Model Number UNKNOWN BARRX 360
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atrial Fibrillation (1729); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Stenosis (2263); Laceration(s) of Esophagus (2398)
Event Date 01/22/2020
Event Type  Injury  
Manufacturer Narrative
Title: standard versus simplified radiofrequency ablation protocol for barrett¿s esophagus: comparative analysis of the whole treatment pathway source: endoscopy international open 2020; 08: e189¿e195, published online: 2020-01-22.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of the study performed between january 2007 and august 2017, three patients developed strictures and dilations was done after the radio frequency procedure.
 
Event Description
According to the literature source, a retrospective analysis of collected data on patients receiving rfa between january 2007 and august 2017 was performed.Three patients developed strictures after the radiofrequency ablation (rfa) procedure and were treated with dilation.One patient had symptomatic atrial fibrillation and needed pharmacological cardioversion.One patient had severe chest pain and dysphagia within 48hr of rfa and was admitted, but this was not related to esophageal stricture and was managed with analgesia and iv fluids.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
UNKNOWN BARRX 360
Type of Device
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Manufacturer (Section D)
COVIDIEN LP BARRX
covidien gi solutions
sunnyvale CA 94085 4022
MDR Report Key10017675
MDR Text Key191708700
Report Number3004904811-2020-00013
Device Sequence Number1
Product Code GEI
UDI-Device Identifier10884521211599
UDI-Public10884521211599
Combination Product (y/n)N
PMA/PMN Number
K142364
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/01/1999
Device Model NumberUNKNOWN BARRX 360
Device Catalogue NumberUNKNOWN BARRX 360
Was Device Available for Evaluation? No
Date Manufacturer Received08/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
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