BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT

    MDR report key: 1954599 · Received January 10, 2011

    Report

    Report Number
    3005099803-2011-00023
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 22, 2010
    Report Date
    December 22, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - J-TUBE EXCHANGE. THE REPORTED EVENT OF J-TUBE KINKED. THE REPORTED EVENT OF MIGRATION OF J-TUBE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISPOSED OF; 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 AN 80CM 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 J-TUBE WAS PLACED ON (B)(6) 2009. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2010 THE PATIENT EXPERIENCED INCREASED RIGIDITY. THE INTESTINAL TUBE WAS PULLED OUT AND PUSHED BACK IN TO TRY AND RECTIFY THE PROBLEM HOWEVER; IT DID NOT RESOLVE THE ISSUE. AN X-RAY WAS PERFORMED ON (B)(6) 2010 AS WELL AS ON (B)(6) 2010. ON (B)(6) 2010 THE X-RAY SHOWED THERE WAS A KINK ON THE INTESTINAL TUBE IN THE STOMA. THE LOCATION OF THE END OF THE INTESTINAL TUBE WAS IN THE JEJUNUM. THE PATIENT RECEIVED DUODOPA TREATMENT IN THE GASTRIC PORT UNTIL THE EXCHANGE OF THE J-TUBE. ON (B)(6) 2010 THE PATIENT RECEIVED A NEW 80CM TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE). THE PATIENT REMAINED IN THE HOSPITAL UNTIL (B)(6) 2010 DUE TO OTHER MEDICAL PROBLEMS AND HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566380 12472597

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR