BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTLIGHT

    MDR report key: 9434432 · Received December 6, 2019

    Report

    Report Number
    1225698-2019-00038
    Event Type
    Injury
    Date Received
    December 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    CARDIOFOCUS
    Product Code
    OAE
    UDI-DI
    00868976000178
    PMA / PMN Number
    P150026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS ONE OF THREE REPORTED IN AN ADVANCE PUBLICATION AND WAS NOT REPORTED DIRECTLY TO THE MANUFACTURER. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. THE RESPONSE FROM THE TREATING PHYSICIAN WAS THE SOURCE OF THE COMPLICATION WAS UNKNOWN YET MOST LIKELY NOT DIRECTLY RELATED TO THE MANUFACTURER'S DEVICE. HOWEVER, SINCE THE CAUSE OF THE ADVERSE EVENT CANNOT BE DETERMINED, THIS EVENT IS BEING REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE ISSUED. THE PUBLICATION IS CIRCULATION JOURNAL, DOI: 10.1253/CIRCJ.CJ-19-0766. TRANSIENT ISCHEMIC ATTACK IS A KNOWN POTENTIAL ADVERSE EVENT FOR CATHETER ABLATION PROCEDURES.

    Description of Event or Problem · 1

    AN ADVANCE LITERATURE PUBLICATION REPORTED A PERIPROCEDURAL TRANSIENT ISCHEMIC ATTACK OF UNKNOWN SOURCE DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. THE SYMPTOMS COMPLETELY RESOLVED DURING THE HOSPITAL STAY. NO PRODUCT INFORMATION WAS PROVIDED AND NO DEVICE DEFICIENCY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223778 HEARTLIGHT HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON OAE CARDIOFOCUS 18-4000-27A 00868976000178

    Patients

    Seq Age Sex Outcome Treatment
    1 Other