BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSITUCATH VALVULOTOME

    MDR report key: 13098 · Received May 5, 1994

    Report

    Report Number
    MW1001855
    Event Type
    Malfunction
    Date Received
    May 5, 1994
    Date of Event
    February 2, 1994
    Report Date
    April 25, 1994
    Manufacturer
    AESCULAP INSTRUMENTS CORP.
    Product Code
    MGZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING VALVULOTOMY WITH IN-SITU CATHETER, THE TIP OF THE CATHETER FELL OFF. THE TIP OF THE CATHETER WAS RETRIEVED WITHOUT ANY DIFFICULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSITUCATH VALVULOTOME INSITUCATH VALVULOTOME MGZ AESCULAP INSTRUMENTS CORP. 2/3084

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other