BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTRACKER-18 INFUSION CATHETER

    MDR report key: 430844 · Received November 26, 2002

    Report

    Report Number
    6000078-2002-00188
    Event Type
    Malfunction
    Date Received
    November 26, 2002
    Date of Event
    October 25, 2002
    Report Date
    November 26, 2002
    Manufacturer
    TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC/TARGET WAS NOTIFIED THAT THE MARKER OF THE FASTRACKER-18 INFUSION CATHETER FRACTURED DURING THE PROCEDURE. THE FRACTURED MARKER REMAINED INSIDE THE PT'S MHA, AND CANNOT BE REMOVED BY ANY DEVICE. THE CUSTOMER ALLEGED THAT HE DID NOT FEEL ANY RESISTANT PRIOR TO THE FRACTURE OF THE CATHETER DURING THE PROCEDURE. THE GUIDEWIRE USED DURING THE PROCEDURE (TRANSEND .014" WAS DISPOSED AT THE HOSP). THE PT WAS REPORTED IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FASTRACKER-18 INFUSION CATHETER INFUSION CATHETER DQO TARGET THERAPEUTICS/A DIVISION OF BOSTON SCIENTIFIC CORP. * 4329002

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO TRANSEND .014" GUIDEWIRE.