BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXIMA REGULAR NEPHROSTOMY CATHETER SYSTEM

    MDR report key: 1012346 · Received February 12, 2008

    Report

    Report Number
    2134265-2008-00748
    Event Type
    Injury
    Date Received
    February 12, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFA
    PMA / PMN Number
    K944290
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND REVEALED NO RELATED ISSUES TO THIS COMPLAINT. CUSTOMER COMPLAINT NOT CONFIRMED. FROM THE INFO PROVIDED IN THE EVENT DESCRIPTION THE MOST PROBABLE ROOT CAUSE IS THAT THE USER PLACED ALCOHOL IN THE DEVICE. THE DFU STATES, "CAUTION: DO NOT ALLOW ALCOHOL TO COME IN CONTACT WITH CATHETER. EXPOSING THE CATHETER TO ALCOHOL MAY DAMAGE THE COATING AND THE CATHETER." THE IDENTIFIED POTENTIAL ROOT CAUSE FOR THIS POTENTIAL FAILURE MODE THAT APPEARS TO BE RELATED IS MATERIAL DEGRADATION. THE IDENTIFIED POTENTIAL ROOT CAUSE APPEARS TO BE RELATED TO THE FAILURE MODE OF THE COMPLAINT DUE TO THE DEVICE BREAKING AFTER IT CAME INTO CONTACT WITH THE ALCOHOL. ALL OTHER IDENTIFIED POTENTIAL ROOT CAUSES DO NOT APPEAR TO BE RELATED, BECAUSE THEY ARE NOT A RESULT OF AN INTERACTION WITH THE ALCOHOL. THE ROOT CAUSE OF THIS COMPLAINT WAS DETERMINED TO BE USER/USE ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTION FOR A LYMPHOCELE DRAINAGE PROCEDURE, THE CATHETER CONSISTENCY CHANGED. THE PHYSICIAN USED THE CATHETER TO ENTER A LYMPHOCELE AND DRAIN IT. A SCLEROSING AGENT (DEHYDRATED 98% ALCOHOL) WAS INJECTED AND THE CATHETER WAS CLAMPED. THIS FACILITY REPORTEDLY ROUTINELY PERFORMS THIS PROCEDURE, AND THE PATIENT IS THEN SENT BACK TO THE FLOOR FOR 2-4 HRS AND THEN THE SCLEROSING AGENT IS DRAINED. IN THIS CASE, THE PATIENT WAS SENT BACK TO THE FLOOR AND WAS REPOSITIONED TO COAT THE LYMPHOCELE. AT THAT TIME, WETNESS/DRAINAGE WAS NOTICED COMING FROM THE CATHETER, EXTERNAL TO THE PATIENT. IT APPEARED THAT THERE WAS A SLIT IN THE CATHETER. THE NURSE NOTED THAT THE CATHETER DID NOT FEEL THE SAME, IT FELT "GUMMY/MUSHY". THE PATIENT WAS TAKEN TO RADIOLOGY FOR REMOVAL OF THE CATHETER UNDER CT GUIDANCE. WHEN THEY ATTEMPTED TO PUT THE GUIDEWIRE BACK IN, THE CATHETER "FELL APART". THE PATIENT WAS BROUGHT IN TO THE OR THAT EVENING TO HAVE CATHETER SURGICALLY REMOVED. THE SURGEON WAS ABLE TO OPEN THE PUNCTURE SITE AND FOLLOW THE TRACK OF TUBE AND REMOVE IT INTACT. THE PATIENT DID WELL POST OPERATIVELY AND WAS DISCHARGED THE NEXT DAY. THE RADIOLOGY NURSE STATED THAT THIS TYPE OF CATHETER IS OFTEN USED TO DRAIN ABSCESSES. IN THIS CASE, ONCE THE ALCOHOL WAS ADDED TO THE CATHETER, IT CHANGED THE CATHETER CONSISTENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA REGULAR NEPHROSTOMY CATHETER SYSTEM FFA - TUBE, DRAINAGE, SUPRAPUBIC FFA BOSTON SCIENTIFIC CORPORATION M001271870 8687053

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention