BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARRX

    MDR report key: 20398684 · Received October 8, 2024

    Report

    Report Number
    3004904811-2024-00022
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 14, 2024
    Manufacturer
    COVIDIEN LP BARRX
    Product Code
    GEI
    PMA / PMN Number
    K092487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE GENERATOR 1190A-115A, S/N: (B)(6) HAS FOUND TO BE NO MALFUNCTION REPORTED BY THE CUSTOMER AND PERFORMED AS EXPECTED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: 90-9200 - 90-9200 BARRX ULTRA LONG RFA FOCAL CATH, LOT# B000002856 90-9200 - 90-9200 BARRX ULTRA LONG RFA FOCAL CATH, LOT# B000003051 UNK-BARRX - UNKNOWN BARRX, LOT# UNKNOWN MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE RFA (RADIO FREQUENCY ABLATION) PROCEDURE, THE OUTPUT CABLE WOULD NOT CONNECT TO THE OUTPUT CONNECTION ON TWO CATHETERS. THE PATIENT HAD A TEAR IN UPPER ESOPHAGUS WHEN TRYING TO REMOVE THE CATHETER. THREE CLIPS WERE PLACED ON TEAR TO ALLOW FOR HEALING. THE CUSTOMER PULLED A NEW CATHETER. THE PATIENT WAS ABLE TO LEAVE THE HOSPITAL THE SAME DAY AFTER CHEST X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636621 BARRX ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN LP BARRX 1190A-115A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11