BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    MDR report key: 1128258 · Received August 20, 2008

    Report

    Report Number
    2134265-2008-02405
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    July 28, 2008
    Report Date
    July 28, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQO
    PMA / PMN Number
    K923480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE TIP OF THE CHOICE PT GUIDEWIRE DETACHED INSIDE THE PT. THE BROKEN PIECE WAS RETRIEVED WITHOUT OPERATION. NO PT INJURIES OR COMPLICATIONS WERE REPORTED. PT STATUS POST PROCEDURE IS NOTED AS OK. ADD'L INFO REGARDING THIS EVENT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC PT GRAPHIX+ (5PK) DQO BOSTON SCIENTIFIC 12161-01 0011627191

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention