BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTLIGHT

    MDR report key: 9434434 · Received December 6, 2019

    Report

    Report Number
    1225698-2019-00040
    Event Type
    Injury
    Date Received
    December 6, 2019
    Date of Event
    May 31, 2018
    Report Date
    December 6, 2019
    Manufacturer
    CARDIOFOCUS
    Product Code
    DRA
    UDI-DI
    00868976000147
    PMA / PMN Number
    K152310
    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. THE PHYSICIAN REPORTED THE ADVERSE EVENT WAS NOT DIRECTLY RELATED TO THE DEVICE. HOWEVER, CAUSALITY COULD NOT BE ESTABLISHED SO THE EVENT IS BEING REPORTED. VASCULAR DAMAGE IS A KNOWN POTENTIAL ADVERSE EVENT OF CATHETER ABLATION PROCEDURES.

    Description of Event or Problem · 1

    AN ADVANCE LITERATURE PUBLICATION REPORTED A VASCULAR ACCESS COMPLICATION IN A PULMONARY VEIN ISOLATION (PVI) PROCEDURE. THE PATIENT DEVELOPED A SEVERE GROIN HEMATOMA, WHICH WAS TREATED BY BLOOD TRANSFUSION. NO SURGICAL INTERVENTION WAS NECESSARY. NO PRODUCT INFORMATION WAS PROVIDED AND NO DEVICE DEFICIENCY REPORTED. THE VASCULAR ACCESS COMPLICATION WAS REPORTED AS NOT DIRECTLY RELATED TO THE MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223780 HEARTLIGHT HEARTLIGHT DEFLECTABLE SHEATH DRA CARDIOFOCUS 18-3356 00868976000147

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other