BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V18 CONTROL WIRE

    MDR report key: 832985 · Received March 16, 2007

    Report

    Report Number
    6000130-2007-00052
    Event Type
    Malfunction
    Date Received
    March 16, 2007
    Date of Event
    February 15, 2007
    Report Date
    February 15, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    k033742
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) # IS K934359.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSHEPATIC CHOLONGIOGRAM, THE V18 GUIDEWIRE FRACTURED. THE CUSTOMER STATED THAT, "[THE PHYSICIAN] USED THE V18 CONTROL WIRE ON THE PT, PT HAD A VERY TIGHT LESION, AND TORTUOUS ANATOMY, [THE PHYSICIAN] COULDN'T GET THE WIRE THROUGH THE LESION, HE APPLIED MORE PRESSURE AND THE TIP BREAK OFF. HAD TO GO IN WITH A DEVICE FROM ANOTHER COUNTRY'S HEALTH CARE TO SNARE THE TIP, TO GET IT OUT OF THE PT. [THE PHYSICIAN] DECIDED TO STOP THE PROCEDURE AFTER THE INCIDENT. NO COMPLICATIONS TO THE PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V18 CONTROL WIRE DQX WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORP NA 9003370

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR