BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTLIGHT

    MDR report key: 8103541 · Received November 26, 2018

    Report

    Report Number
    1225698-2018-00021
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 18, 2018
    Report Date
    November 26, 2018
    Manufacturer
    CARDIOFOCUS
    Product Code
    OAE
    UDI-DI
    00868976000178
    PMA / PMN Number
    P150026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROCEDURE WAS COMPLETED WITH NO PROBLEMS ON (B)(6) 2018 AS PART OF THE (B)(6) STUDY BUNDLED UNDER P150026 AND P150026/S002, PROTOCOL NO. (B)(6). NO DEVICE DEFICIENCY WAS REPORTED. THE ADVERSE EVENT WAS FIRST REPORTED BY THE PATIENT ON (B)(6) 2018. CARDIOFOCUS WAS MADE AWARE OF THE ADVERSE EVENT ON 7-NOV-2018 BY THE STUDY SITE. ESOPHAGEAL ULCERATION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH ANY CARDIAC ABLATION PROCEDURE. THERE IS NO ADDITIONAL INFORMATION FOR THIS ADVERSE EVENT. IF ANY INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABLATION WAS DONE ON (B)(6) 2018 AND ON (B)(6) 2018 THE PATIENT RETURNED WITH CHEST PAIN. PATIENT WAS DIAGNOSED WITH ESOPHAGEAL ULCER AND WAS TREATED MEDICALLY AND DISCHARGED ON (B)(6) 2018. PATIENT WAS BACK TO BASELINE AT FOLLOW-UP VISIT ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    943816 HEARTLIGHT HEARTLIGHT EXCALIBUR BALLOON CATHETER OAE CARDIOFOCUS 18-4000-27A 10697-006 00868976000178

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| O