BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKRO-CATH

    MDR report key: 11632116 · Received April 7, 2021

    Report

    Report Number
    1625382-2017-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    May 24, 2017
    Report Date
    June 29, 2017
    Manufacturer
    MILLAR INC.
    Product Code
    DXO
    PMA / PMN Number
    K093111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IMPLANTED FOR GREATER THAN THE 24 HOURS AS SPECIFIED BY THE IFU. THE DOCTOR ALSO FAILED TO USE A GUIDEWIRE AS RECOMMENDED IN THE IFU.

    Description of Event or Problem · 1

    THE SURGICAL TEAM'S PHYSICIAN ASSISTANT ATTEMPTED TO REMOVE THE CATHETER FROM THE PATIENT BY PULLING THE CATHETER FROM THE CHEST WALL AT THE BED SIDE. THE PHYSICIAN ASSISTANT FELT RESISTANCE WHILE ATTEMPTING TO PULL THE CATHETER OUT AT THE END OF THE PROCEDURE. THE DOCTOR (IMPLANTING PHYSICIAN) MET WITH THE PATIENT AND THEY DECIDED TO CUT THE CATHETER LEAD AT THE SKIN SITE. IT HAS NOT BEEN CONFIRMED HOW MUCH OF THE CATHETER LENGTH WAS LEFT IN THE PATIENT. PER THE DOCTOR, HE BELIEVES THE CATHETER TIP AND REMAINING LENGTH IS LOCATED IN THE CHEST OUTSIDE OF THE HEART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529063 MIKRO-CATH MIKRO-CATH PRESSURE TRANSDUCER CATHETER DXO MILLAR INC. 825-0101

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other