BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE¿ JEJUNAL FEEDING TUBE

    MDR report key: 6134924 · Received November 30, 2016

    Report

    Report Number
    3005099803-2016-03660
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    October 12, 2016
    Report Date
    November 9, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    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

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON'S DISEASE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE JEJUNAL TUBE WAS CLOGGED. WHILE WAITING FOR THE REPLACEMENT, THE ADMINISTRATION OF DUODOPA WAS REPORTEDLY ADMINISTERED THROUGH THE GASTRIC PORT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON'S DISEASE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE JEJUNAL TUBE WAS CLOGGED. WHILE WAITING FOR THE REPLACEMENT, THE ADMINISTRATION OF DUODOPA WAS REPORTEDLY ADMINISTERED THROUGH THE GASTRIC PORT. 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. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 4, 2016. IT WAS REPORTED THE JEJUNAL TUBE MIGRATED. REPORTEDLY, ¿THE GASTROENTEROLOGIST HAS NOTED THAT THE INTESTINAL TUBE WAS ABSENT (LOST IN THE INTESTINAL TRACT.)¿

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON'S DISEASE. THE PROCEDURE WAS PERFORMED ON (B)(6) 2015. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2016, THE JEJUNAL TUBE WAS CLOGGED. WHILE WAITING FOR THE REPLACEMENT, THE ADMINISTRATION OF DUODOPA WAS REPORTEDLY ADMINISTERED THROUGH THE GASTRIC PORT. 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. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 4, 2016. IT WAS REPORTED THE JEJUNAL TUBE MIGRATED. REPORTEDLY, ¿THE GASTROENTEROLOGIST HAS NOTED THAT THE INTESTINAL TUBE WAS ABSENT (LOST IN THE INTESTINAL TRACT.)¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785150 ENDOVIVE¿ JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00566380

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR DUODOPA