BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRX 360

    MDR report key: 16277245 · Received February 1, 2023

    Report

    Report Number
    3004904811-2023-00002
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    May 1, 2022
    Report Date
    February 1, 2023
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: SPRAY CRYOTHERAPY VERSUS CONTINUED RADIOFREQUENCY ABLATION IN PERSISTENT BARRETT¿S ESOPHAGUS SOURCE: DISEASES OF THE ESOPHAGUS (2022), 35, 1¿7. CONCOMITANT PRODUCT/S: PRODUCT ID: UNK-BARRX CATALOG #: UNKNOWN BARRX, LOT #: UNK. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY FROM 2005 TO 2020 ANALYZED OUTCOMES OF 46 PATIENTS WITH PERSISTENT BARRETT¿S ESOPHAGUS (PBE) WHO WERE UNDER TREATMENT USING RADIOFREQUENCY ABLATION (RFA) AND MULTIMODAL ADJUNCT THERAPY WITH OR WITHOUT THE ADDITION OF SPRAY CRYOTHERAPY. TWENTY-THREE PATIENTS IN THE RFA GROUP WERE TREATED WITH THE HALO 360 WITH THE REPORTED COMPLICATION OF ESOPHAGEAL STRICTURES. THE AUTHORS DID NOT PROVIDE DETAILS ON ANY MEDICAL INTERVENTIONS WHICH MAY HAVE BEEN REQUIRED FOR THE TREATMENT OF THE REPORTED ESOPHAGEAL STRICTURES. ARTICLE NAME: SPRAY CRYOTHERAPY VERSUS CONTINUED RADIOFREQUENCY ABLATION IN PERSISTENT BARRETT'S ESOPHAGUS AUTHORS: GENERE J.R., VISRODIA K., ZAKKO L., HOEFNAGEL S.J.M., WANG K.K. YEAR: 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775400 BARRX 360 ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN LP BARRX UNKNOWN BARRX 360

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention