BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 18292629 · Received December 8, 2023

    Report

    Report Number
    3011610434-2023-00013
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 10, 2023
    Report Date
    December 8, 2023
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    NLH
    PMA / PMN Number
    K182386
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAME AWARE ON 10-NOV-2023 OF A REPROCESSED SUPREME DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER FROM NOVANT HEALTH NEW HANOVER REGIONAL MEDICAL CENTER REPORTED TO HAVE BEEN PLACED IN THE CORONARY SINUS AND THERE WAS A RESULTING CORONARY DISSECTION THAT OCCURRED DURING THE PROCEDURE. ANOTHER INNOVATIVE HEALTH DEVICE WAS USED DURING THE PROCEDURE THAT WAS NOT REPORTED TO HAVE BEEN IN USE WHEN THE INJURY OCCURRED. IT WAS COMMUNICATED BY THE HOSPITAL THAT THE PATIENT DID NOT SUFFER ANY ADDITIONAL COMPLICATIONS BEYOND THE CORONARY DISSECTION AND NO PERICARDIAL DRAIN WAS PLACED DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED WITHOUT FURTHER COMPLICATIONS. NO DEVICE MALFUNCTIONS WERE REPORTED BY THE HOSPITAL RELATED TO THE REPROCESSED SUPREME CATHETER. PER INNOVATIVE HEALTH INDICATIONS FOR USE, THE REPROCESSED SUPREME DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS CAN BE USED IN THE EVALUATION OF A VARIETY OF CARDIAC ARRHYTHMIAS FROM ENDOCARDIAL AND INTRAVASCULAR SITES. THE DEVICE WAS RETURNED FOR INVESTIGATION ON 30-NOV-2023. UPON VISUAL INSPECTION OF THE DEVICE, NO DAMAGE OR DEFECTS WERE NOTED. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. THE DEVICE PASSED ALL INSPECTION CRITERIA AT THE TIME OF MANUFACTURING AND AGAIN UPON COMPLAINT INVESTIGATION. THEREFORE, BASED ON THE INFORMATION AVAILABLE, INNOVATIVE HEALTH CANNOT CONFIRM THERE WERE PERFORMANCE ISSUES WITH THE REPROCESSED SUPREME DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER.

    Description of Event or Problem · 0

    AS THE DEVICE WAS BEING PLACED IN THE CORONARY SINUS, THERE WAS A RESULTING DISSECTION OF THE CORONARY SINUS DURING THE PROCEDURE. ANOTHER INNOVATIVE HEALTH DEVICE WAS USED DURING THE PROCEDURE THAT WAS NOT REPORTED TO HAVE BEEN IN USE WHEN THE DISSECTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220334 N/A DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER NLH INNOVATIVE HEALTH, LLC. 401863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown