BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SGW STAB PLUS .014 180CM J SS

    MDR report key: 673060 · Received February 2, 2006

    Report

    Report Number
    1016427-2005-00301
    Event Type
    Malfunction
    Date Received
    February 2, 2006
    Date of Event
    November 22, 2005
    Report Date
    December 27, 2005
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PTCA HAD BEEN SUCCESSFULLY COMPLETED ON A PATIENT. WHILE REMOVING THE WIRE, HOWEVER, THE COIL AT THE TIP UNRAVELED. AFTER SOME PULLING, THE WIRE WAS SAFELY REMOVED. THERE NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGW STAB PLUS .014 180CM J SS CARDIOLOGY WIRES AND METALS DQX CORDIS CORPORATION NA X0405524

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR