BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTRACKER-10

    MDR report key: 64503 · Received January 17, 1997

    Report

    Report Number
    2939204-1997-90008
    Event Type
    Malfunction
    Date Received
    January 17, 1997
    Report Date
    January 17, 1997
    Manufacturer
    TARGET THERAPEUTICS, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE CO DISTRIBUTOR IN GERMANY SENT A REPORT THAT STATED "DURING GIVING THE FIRST CONTRAST MEDIA, BOTH CATHETERS RUPTURED." TWO CATHETERS WERE RETURNED FROM THE SAME PROCEDURE. THESE ARE REPORTED AS M961155 AND M96116.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTRACKER-10 CATHETER DQO TARGET THERAPEUTICS, INC. 135XXX A39560

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR