BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 11810186 · Received May 11, 2021

    Report

    Report Number
    3011610434-2021-00010
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 11, 2021
    Manufacturer
    INNOVATIVE HEALTH, LLC.
    Product Code
    NLG
    UDI-DI
    10841898130731
    PMA / PMN Number
    K200212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INNOVATIVE HEALTH, LLC BECAME AWARE ON 12-APR-2021 OF A REPORT FROM (B)(6) HOSPITAL ON AN ADVISOR HD GRID SENSOR ENABLED HIGH DENSITY MAPPING CATHETER. THIS DEVICE EXPERIENCED A CRACK ON ITS TIP DURING INSERTION. THE PATIENT WAS NOT INJURED AND CASE CONTINUED WITH A DIFFERENT DEVICE. INNOVATIVE HEALTH RECEIVED THE DEVICE FOR EVALUATION ON 19-APR-2021. A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE, AND THE TIP WAS CONFIRMED TO BE CRACKED/DAMAGED. NO FURTHER DAMAGE WAS IDENTIFIED. A TACTILE INSPECTION WAS PERFORMED, AND NO BENDS OR KINKS WERE NOTED. A VISUAL INSPECTION OF THE TIP STRAIGHTENER PROVIDED WITH THE DEVICE WAS PERFORMED, AND NO DAMAGE WAS NOTED.

    Description of Event or Problem · 1

    THE TIP OF AN ADVISOR HD GRID CATHETER WAS REPORTED TO BE CRACKED DURING INSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705385 N/A HIGH DENSITY MAPPING CATHETER NLG INNOVATIVE HEALTH, LLC. D-AVHD-DF16 10841898130731

    Patients

    Seq Age Sex Outcome Treatment
    1