BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMETRA CATHETER

    MDR report key: 3832097 · Received March 7, 2014

    Report

    Report Number
    3006803715-2014-00005
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    February 7, 2014
    Report Date
    February 7, 2014
    Manufacturer
    FLOWONIX MEDICAL, INC.
    Product Code
    LKK
    PMA / PMN Number
    P080012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING EVALUATED AT THE MFG SITE. WHEN THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED A CATHETER OCCLUSION. A CONTRAST DYE PROCEDURE WAS COMPLETED AND AN OCCLUSION WAS CONFIRMED TO BE CLOSE TO THE SUTURE WING. THE PHYSICIAN REMOVED THE PORTION OF THE CATHETER WITH THE SUTURE WING, USED A REVISION KIT TO REATTACH THE CATHETER AND WAS ABLE TO VERIFY PROPER CSF FLOW. IT WAS REPORTED THAT THE PT IS VERY OBESE AND THE PHYSICIAN IS UNSURE IF THAT COULD HAVE AFFECTED THE CONNECTION. THE CATHETER REMAINS IMPLANTED BUT THE PORTION OF THE CATHETER WITH THE SUTURE WING HAS BEEN RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138635 PROMETRA CATHETER IMPLANTABLE LKK FLOWONIX MEDICAL, INC. 11823 18730

    Patients

    Seq Age Sex Outcome Treatment
    1