BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONICATH ULTRA 3.2

    MDR report key: 1221427 · Received October 30, 2008

    Report

    Report Number
    1221427
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 30, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR NOTICED THAT THE CATHETER WAS DAMAGED, BUT FELT THAT THE DAMAGE COULD HAVE BEEN CAUSED BY THE SHEATH USED. THE CATHETER WOULD NOT WORK AND WAS REMOVED AND REPLACED WITH A NEW CATHETER. THE PATIENT WAS NOT INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SONICATH ULTRA 3.2 CATHETER, ULTRASOUND, INTRAVASCULAR ITX BOSTON SCIENTIFIC CORP. * 8996832

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR