BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIKRO-CATH CARDIOVASCULAR CATHETER

    MDR report key: 3650156 · Received February 12, 2014

    Report

    Report Number
    1625382-2014-00001
    Event Type
    Injury
    Date Received
    February 12, 2014
    Date of Event
    January 17, 2014
    Report Date
    February 11, 2014
    Manufacturer
    MILLAR, INC.
    Product Code
    OBI
    PMA / PMN Number
    K093111
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO HOURS AFTER A CATHETERIZATION PROCEDURE, THE PATIENT SUFFERED A STROKE. THE USER FACILITY STATED THAT THE MIKRO-CATH PERFORMED AS INDICATED DURING THE PROCEDURE. THE DEVICE WAS DISCARDED AS THERE WAS NO INDICATION THAT THERE WAS A PROBLEM WITH THE PROCEDURE. THE PATIENT WAS PART OF A CLINICAL TRIAL. THERE WERE OTHER DEVICES AND DRUGS USED DURING THE PROCEDURE. AS STATED ABOVE, THE MILLAR INC. CATHETER WAS USED AND PERFORMED AS INDICATED. THE USER FACILITY STATED THEY HAD NO ISSUES WITH THE MIKRO-CATH CATHETER. THE DEVICE WAS DISCARDED AFTER USE AS THERE WAS NO INDICATION OF ANY PROBLEM WITH THE CATHETER. THIS REPORT IS BEING FILED BECAUSE OUR DEVICE WAS USED DURING THE PROCEDURE, BUT IS NOT SUSPECTED TO HAVE CAUSED THE MEDICAL ISSUE. THE PROCEDURE TOOK PLACE AS PART OF A CLINICAL TRIAL. MULTIPLE DEVICES AND DRUGS WERE USED DURING THE PROCEDURE. THE DEVICE WAS NOT RETURNED BY THE USER FACILITY, THEREFORE, NO FURTHER INVESTIGATION OF THE DEVICE CAN BE PERFORMED. THE USER FACILITY STATED THE DEVICE PERFORMED AS INDICATED.

    Description of Event or Problem · 1

    A USER FACILITY WAS USING A SERIES OF MEDICAL DEVICES DURING A CLINICAL TRIAL. TWO HOURS AFTER THE CATHETERIZATION PROCEDURE, THE PATIENT HAD A STROKE. THE USER FACILITY STATED THAT THE MIKRO-CATH PERFORMED AS INDICATED DURING THE PROCEDURE. THE DEVICE WAS DISCARDED AFTER THE PROCEDURE, AS THERE WAS NO INDICATION THAT THERE WAS A PROBLEM WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91453 MIKRO-CATH CARDIOVASCULAR CATHETER CATHETER, PRESSURE MONITORING CARDIAC OBI MILLAR, INC. MIKRO-CATH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other