BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 11507300 · Received March 17, 2021

    Report

    Report Number
    3011610434-2020-00001
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    October 5, 2020
    Report Date
    December 9, 2020
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    NLH
    PMA / PMN Number
    K190127
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INNOVATIVE HEALTH, LLC BECAME AWARE OF THIS EVENT ON 11-NOV-2020 VIA LETTER FROM THE ORIGINAL MANUFACTURER. INNOVATIVE HEALTH CONTACTED THE HEALTHCARE FACILITY TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT ON (B)(6) 2020 AND AGAIN ON (B)(6) 2020 FOR FOLLOW UP INFORMATION. BASED ON THE INFORMATION OBTAINED FROM THE HEALTHCARE FACILITY, THERE WERE NO REPORTS OF PERFORMANCE ISSUES WITH THE REPROCESSED LIVEWIRE CATHETER. FURTHER INVESTIGATION COULD NOT BE COMPLETED SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE SERIAL NUMBER IS UNKNOWN. THIS MDR REPORT WAS SUBMITTED TO THE FDA ON 11-DEC-2020 AND ACKNOWLEDGMENT OF RECEIPT WAS OBTAINED, HOWEVER, IT WAS NOT PUBLISHED, HENCE REPORT, IT IS BEING RESUBMITTED.

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION ABLATION PROCEDURE, DURING EITHER THE TRANSSEPTAL PUNCTURE OR DURING INITIAL MAPPING, A CARDIAC PERFORATION OCCURRED. AFTER THE TRANSSEPTAL PUNCTURE WAS PERFORMED UNDER INTRACARDIAC ECHOCARDIOGRAPHY WITH A GUIDEWIRE (NON-INNOVATIVE HEALTH PRODUCT) THROUGH A BRK NEEDLE (NON-INNOVATIVE HEALTH PRODUCT), THE REPROCESSED INNOVATIVE HEALTH CATHETER WAS INTRODUCED INTO THE LEFT ATRIUM. WHILE CREATING THE GEOMETRY, A PERICARDIAL EFFUSION WAS NOTED ON INTRACARDIAC ECHOCARDIOGRAPHY IN THE DOME OF THE LEFT ATRIUM AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS NOTED TO BE HYPOTENSIVE. THE PATIENT WENT INTO SURGERY WHERE A PERICARDIOCENTESIS WAS PERFORMED, VASOPRESSORS AND BLOOD TRANSFUSIONS WERE GIVEN, AND THORACIC SURGICAL INTERVENTION WAS CONDUCTED TO REPAIR THE TEAR IN THE DOME OF THE LEFT ATRIUM. THE PATIENT WAS NOTED TO BE IN A STABLE CONDITION. THERE WERE NO PERFORMANCE ISSUES WITH THE INNOVATIVE HEALTH REPROCESSED LIVEWIRE CATHETER USED DURING THIS PROCEDURE AS CONFIRMED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405871 N/A DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER NLH INNOVATIVE HEALTH, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention