BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 20392610 · Received October 7, 2024

    Report

    Report Number
    3011610434-2024-00008
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 7, 2024
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    NLG
    UDI-DI
    10841898130731
    PMA / PMN Number
    K212776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAME AWARE ON 27-AUG-2024 OF A REPROCESSED ADVISOR HD GRID SENSOR ENABLED HIGH DENSITY MAPPING CATHETER REPORTED THAT "THE CHEATER WAS NOT BE ABLE TO GUIDE THE GRID INTO THE SHEATH". ADDITIONAL INFORMATION WAS REQUESTED FROM THE FACILITY ON 3-OCT-2024 RELATED TO THE USE OF THE DEVICE WITHIN THE PROCEDURE AND IT WAS REPORTED THAT THE CATHETER WOULD NOT ADVANCE ONTO THE SHEATH WITHOUT USING A GREAT AMOUNT OF FORCE. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR INVESTIGATION ON 30-AUG-2024. THE DEVICE WAS VISUALLY INSPECTED AND DEFORMATION OF THE DISTAL PADDLE WAS OBSERVED. UPON INSPECTION, IT APPEARED THAT A PORTION OF THE DISTAL PADDLE INSULATION LAYER HAD BEEN TORN OFF. THE INSERTION TOOL WAS RETURNED WITH THE CATHETER AND THE TOOL WAS FOUND TO HAVE THE DISTAL END FRACTURED. THE FRACTURED END OF THE INSERTION TOOL WAS NOT RETURNED FOR INVESTIGATION. NO OTHER DAMAGE OR DEFECTS WERE OBSERVED. NO INJURIES OR CLINICAL SIGNS/SYMPTOMS WERE REPORTED. PER THE INSTRUCTIONS FOR USE: "EXCESSIVE BENDING OR KINKING OF THE CATHETER MAY CAUSE DAMAGE TO THE CATHETER. DO NOT USE IF THE CATHETER APPEARS DAMAGED, KINKED, OR IF THERE IS DIFFICULTY IN DEFLECTING THE DISTAL SECTION TO ACHIEVE THE DESIRED CURVE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CHEATER WAS NOT ABLE TO GUIDE THE GRID INTO THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247225 N/A HIGH DENSITY MAPPING CATHETER NLG INNOVATIVE HEALTH, LLC. D-AVHD-DF16 10841898130731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown