BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIMA APDL DRAINAGE CATHETER

    MDR report key: 2568650 · Received May 4, 2012

    Report

    Report Number
    MW5025330
    Event Type
    Other
    Date Received
    May 4, 2012
    Date of Event
    April 2, 2012
    Report Date
    May 4, 2012
    Manufacturer
    BOSTON SCIENTIFIC CORP
    Product Code
    FGE
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT SCHEDULED AS OUTPATIENT FOR RIGHT RENAL CYST ASPIRATION WITH SCLEROSING. DEHYDRATED ALCOHOL 85ML WAS INSTILLED INTO CYST AND PT WAS POSITIONED IN MULTIPLE POSITIONS OVER 30 MINUTES. ALL 85ML OF ALCOHOL WAS REMOVED AND 8FR ABSCESSION CATHETER WAS REMOVED. IT WAS NOTED AT THAT TIME THAT THE CATHETER WAS NOT COMPLETELY INTACT. PT WAS POSITIONED BACK ONTO FLUORO TABLE AND THE MISSING REMAINDER OF CATHETER WAS NOTED IN THE RIGHT RENAL CYST. PT WAS TAKEN TO CT TO ATTEMPT TO REMOVE THE REMAINDER OF THE CATHETER. CATHETER WAS APPROXIMATELY POSITIONED 10CM FROM INSERTION SITE. DOCTOR ATTEMPTED TO GAIN ACCESS TO REMOVE FOREIGN BODY, BUT WAS UNSUCCESSFUL. DECISION WAS MADE AT THAT POINT TO STOP AND CONTACT SURGERY. PT WAS STABLE AND PAIN FREE FOR DURATION OF PROCEDURE. SURGERY AND UROLOGY WERE CONTACTED. NOTED IN PRODUCT INSERT AFTER EVENT THAT THIS PRODUCT WAS NOT TO BE USED WITH ALCOHOL. BURIED ON THIRD PAGE OF INSERT. NOT MARKED ON OUTSIDE OF PRODUCT PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIMA APDL DRAINAGE CATHETER PIGTAIL LOCKING CATHETER FGE BOSTON SCIENTIFIC CORP CE0197 14669439

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR