BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIKRO-TIP CATHETER PRESSURE TRANSDUCER

    MDR report key: 213305 · Received March 9, 1999

    Report

    Report Number
    1625382-1999-00001
    Event Type
    Malfunction
    Date Received
    March 9, 1999
    Date of Event
    November 26, 1998
    Report Date
    February 19, 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 INJECTED LUMEN OF THE 5 FRENCH PIGTAIL-SHAPED TIP CATHETER, BY CLOT FORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR