BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKRO-TIP CATHETER TRANSDUCER

    MDR report key: 219147 · Received April 6, 1999

    Report

    Report Number
    1625382-1999-00003
    Event Type
    Malfunction
    Date Received
    April 6, 1999
    Date of Event
    December 7, 1998
    Report Date
    March 10, 1999
    Manufacturer
    MILLAR INSTRUMENTS, INC.
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OCCLUSION OF AN INJECTION LUMEN OF THE 5 FRENCH PIGTAIL-SHAPED TIP CATHETER, BY CLOT FORMATION WAS THE COMMON EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIKRO-TIP CATHETER TRANSDUCER ANGIOGRAPHIC (CARDIAC) CATHETER DXO MILLAR INSTRUMENTS, INC. SPC-454F UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other