BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INQUIRY

    MDR report key: 3161417 · Received June 3, 2013

    Report

    Report Number
    3161417
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    THE STEERING MECHANISM STOPPED WORKING DURING THE CASE. WE REPLACED THE CATHETER WITH A NEW ONE. CATHETER WAS REMOVED FROM BODY AND REPLACED WITH NEW CATHETER. NO PATIENT HARM OCCURRED. WILL NOTIFY MANUFACTURER REPRESENTATIVE OF DEFECTIVE CATHETER.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243673 INQUIRY CATHETER DSA STRYKER SUSTAINABILITY SOLUTIONS 81531 1688438

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR