BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT

    MDR report key: 1840168 · Received September 21, 2010

    Report

    Report Number
    3005099803-2010-03990
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 14, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    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 ADVANCED STAGE PARKINSON'S DISEASE. THE DATE OF THE PLACEMENT PROCEDURE WAS (B)(4), 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6), 2010, THE J-TUBE WAS IMPOSSIBLE TO RINSE. ON (B)(6), 2010, THE PARKINSON'S NURSE AT THE OUT CLINIC PULLED THE J-TUBE APPROXIMATELY 8CM OUT FROM THE PEG WHILE RINSING THE TUBE. SHE THEN RECONNECTED THE J-TUBE TO THE PEG. THIS RESOLVED THE PROBLEM. BETWEEN THE DATES OF (B)(6), 2010, THE PATIENT WAS GIVEN DUODOPA IN THE GASTRIC PORT. AFTER THE RINSING PERFORMED ON (B)(6), 2010, THE DUODOPA WAS GIVEN THROUGH THE INTESTINAL PORT. THIS DEVICE REMAINS IN USE. ADDITIONAL INFORMATION RECEIVED ON (B)(6), 2010: THE PATIENT'S CONDITION STATES THAT AFTER RINSING THE J-TUBE, THE PATIENT HAS HAD THE ORDINARY EFFECT OF THE DUODOPA TREATMENT.

    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 ADVANCED STAGE PARKINSON'S DISEASE. THE DATE OF THE PLACEMENT PROCEDURE WAS (B)(6), 2010. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON (B)(6), 2010, THE J-TUBE WAS IMPOSSIBLE TO RINSE. ON (B)(6), 2010, THE PARKINSON'S NURSE AT THE OUT CLINIC PULLED THE J-TUBE APPROXIMATELY 8CM OUT FROM THE PEG WHILE RINSING THE TUBE. SHE THEN RECONNECTED THE J-TUBE TO THE PEG. THIS RESOLVED THE PROBLEM. BETWEEN THE DATES OF (B)(6), 2010, THE PATIENT WAS GIVEN DUODOPA IN THE GASTRIC PORT. AFTER THE RINSING PERFORMED ON (B)(6), 2010, THE DUODOPA WAS GIVEN THROUGH THE INTESTINAL PORT. THIS DEVICE REMAINS IN USE. 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
    1 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566380 12946977

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR