BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKRO-CATH PRESSURE CATHETER

    MDR report key: 13957339 · Received March 30, 2022

    Report

    Report Number
    1625838-2022-00001
    Event Type
    Malfunction
    Date Received
    March 30, 2022
    Date of Event
    March 8, 2022
    Report Date
    March 29, 2022
    Manufacturer
    MILLAR INC.
    Product Code
    DXO
    UDI-DI
    00868924000205
    PMA / PMN Number
    K163376
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION. THE INITAL EVALUATION SHOWED THE THERE WAS SOME STRESS ON TEH CATHETER AT TEH POINT OF THE BREAK. TEH INTERNAL WIRES ARE BROKEN, AND IMAGING TAKEN AT MILLAR OF THESE WIRES INDICATES THAT THEY HAVE BEEN STRETCHED BEFORE BREAKING AT THE TEH POINT WHERE TEH CATHETER WAS MARKED WITH A SHARPIE. IT IS OUR UNDERSTANDING THAT THIS IS THE POINT WHERE THE HEMOSTASIS VALVE WAS PLACED AND TIGHTENED TO SECURE THE MIKRO-CATH IN PLACE. TH EPOINT OF THE BREAK SHOWS STRESS.

    Description of Event or Problem · 0

    THE CATHETER BROKE IN TEH PATIENTS BODY AFTER THE PHYSICIAN PULLED THE CATHETER BACK TO THE AO. THE CATHETER WAS PULLED BACK JUST A LITTLE BIT AND THE TIP DID NOT PULL BACK AS THE CATHETER WAS PULLED BACK. IT WAS OBSERVED THE MILLAR CATHETER WAS BROKEN AT APPROXIMATELY 15 CM FROM THE END. PINCHED GUIDE CATHETER AND PULLED ALL OUT EASILY WITH NO RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186048 MIKRO-CATH PRESSURE CATHETER PRESSURE TRANSDUCER DXO MILLAR INC. 825-0101-5 58713 00868924000205

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female