BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 20515945 · Received October 23, 2024

    Report

    Report Number
    3011610434-2024-00009
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    October 8, 2024
    Report Date
    October 23, 2024
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    NLG
    UDI-DI
    10841898130731
    PMA / PMN Number
    K212776
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INNOVATIVE HEALTH LLC BECAME AWARE ON 8-OCT-2024 OF A REPROCESSED ADVISOR HD GRID SENSOR ENABLE HIGH DENSITY MAPPING CATHETER REPORTED THAT "MECHANICAL MALFUNCTION DEVICE BECOME STUCK IN THE SHEATH UPON REMOVAL AND THE PADDLE PORTION HAS DAMAGE TO IT". NO INJURIES OR CLINICAL SIGNS/SYMPTOMS WERE REPORTED. A REVIEW OF THE PROCESS CONTROL RECORD WAS PERFORMED AND NO ANOMALIES WERE NOTED. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR INVESTIGATION ON (B)(6)2024. THE DEVICE WAS VISUALLY INSPECTED AND DEFORMATION OF THE DISTAL PADDLE WAS OBSERVED. UPON INSPECTION, THE DISTAL PADDLE WAS CONFIRMED TO BE FRACTURED IN HALF AND A PORTION OF THE DISTAL PADDLE INSULATION LAYER HAD BEEN TORN OFF. THE INSERTION TOOL WAS RETURNED WITH THE CATHETER AND WAS FOUND TO BE SLIGHTLY BENT OUT OF SHAPE. THE CORDIS INTRODUCER USED DURING THE PROCEDURE, NOT REPROCESSED BY INNOVATIVE HEALTH, WAS RETURNED AND WAS OBSERVED TO HAVE DAMAGE SUSTAINED ON THE DISTAL END OF THE SHEATH. NO OTHER DAMAGE OR DEFECTS WERE OBSERVED. 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

    ON (B)(6)2024, AN INNOVATIVE HEALTH REPRESENTATIVE REPORTED VIA EMAIL THAT THERE WAS A DEVICE WITH A MECHANICAL MALFUNCTION, DEVICE BECOME STUCK IN THE SHEATH UPON REMOVAL AND THE PADDLE PORTION HAS DAMAGE TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38278 N/A HIGH DENSITY MAPPING CATHETER NLG INNOVATIVE HEALTH, LLC. D-AVHD-DF16 10841898130731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown