BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

    MDR report key: 3062020 · Received April 16, 2013

    Report

    Report Number
    3005099803-2013-02586
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) FOR THE REPORTED EVENT OF OCCLUDED J-TUBE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCE STAGE OF PARKINSON'S DISEASE. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINT, THE J-TUBE WAS OBSTRUCTED, WHICH SET OFF THE HIGH PRESSURE ALARM. ATTEMPTS WERE MADE BY THE NURSE TO RESOLVE THE ISSUE BY RINSING HOWEVER THE TUBE REMAINED BLOCK. THE PATIENT, CURRENTLY ON A SUBSTITUTION TREATMENT, HAS AN APPOINTMENT WITH THE GASTROENTEROLOGY UNIT TO ATTEMPT TO REMOVE THE OBSTRUCTION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161985 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK443

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR DUODOPA