BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTLIGHT

    MDR report key: 9434433 · Received December 6, 2019

    Report

    Report Number
    1225698-2019-00039
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    May 17, 2018
    Report Date
    December 6, 2019
    Manufacturer
    CARDIOFOCUS
    Product Code
    OAE
    UDI-DI
    00868976000109
    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 AND LIMITED PATIENT INFORMATION RECEIVED. THERE WAS NO DEVICE DEFICIENCY REPORTED. THE PUBLICATION IS CIRCULATION JOURNAL, DOI: 10.1253/CIRCJ.CJ-19-0766. PHRENIC NERVE DAMAGE LEADING TO DIAPHRAGMMATIC PARALYSIS IS A KNOWN POTENTIAL ADVERSE EVENT OF CATHETER ABLATION PROCEDURES.

    Description of Event or Problem · 1

    AN ADVANCE LITERATURE PUBLICATION REPORTED A PHRENIC NERVE PALSY (PNP) DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE DURING ABLATION OF THE RIGHT SUPERIOR PULMONARY VEIN. THE PATIENT WAS ASYMPTOMATIC. AFTER THREE MONTHS OF FOLLOW-UP THE PNP WAS STILL DETECTED BY FLUOROSCOPY. NO PRODUCT INFORMATION WAS PROVIDED AND NO DEVICE DEFICIENCY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223779 HEARTLIGHT HEARTLIGHT CATHETER WITH EXCALIBUR BALLOON OAE CARDIOFOCUS 18-4000-27A 00868976000109

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other