BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT

    MDR report key: 1680800 · Received May 12, 2010

    Report

    Report Number
    3005099803-2010-02134
    Event Type
    Injury
    Date Received
    May 12, 2010
    Date of Event
    January 14, 2010
    Report Date
    April 23, 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) (6). (B) (4) - EXCHANGE OF J-TUBE. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT MODEL, CATALOG NUMBER AND DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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).

    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 FEEDING TUBE KIT WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION (DUODOPA) FOR ADVANCED STAGE PARKINSON'S DISEASE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON THE EVENING OF (B) (6) 2010, THE PATIENT EXPERIENCED AN OCCLUSION IN THE J-TUBE. THE PATIENT THEN TOOK THE MEDICATION MADOPARK Q. THE NEXT MORNING, THE PATIENT EXPERIENCED FLUCTUATIONS AND CONTACTED A PARKINSON'S NURSE AT THE HOSPITAL. THEN, THE PATIENT BEGAN TO TAKE DUODOPA AT THE SIDE PORT OF THE Y CONNECTOR AND PERIODICALLY RINSED THE DEVICE. THE PATIENT WAS GIVEN AN X-RAY AND THE INTESTINAL TUBE WAS FOUND TO BE DISLOCATED AND KINKED WITHIN THE STOMACH. THIS INTESTINAL TUBE WAS REMOVED ON (B) (6) 2010 AND THE PROCEDURE WAS COMPLETED WITH AN 80CM ENDOVIVE TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE DEVICE. ATTEMPTS TO OBTAIN MORE COMPLETE 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 FEEDING TUBE KIT WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION (DUODOPA) FOR ADVANCED STAGE PARKINSON'S DISEASE. THE TUBE WAS PLACED ON (B)(6), 2009. ACCORDING TO THE COMPLAINANT, POST PROCEDURE ON THE EVENING OF (B)(6), 2010, THE PATIENT EXPERIENCED AN OCCLUSION IN THE J-TUBE. THE PATIENT THEN TOOK THE MEDICATION MADOPARK Q. THE NEXT MORNING, THE PATIENT EXPERIENCED FLUCTUATIONS AND CONTACTED A PARKINSON'S NURSE AT THE HOSPITAL. THEN, THE PATIENT BEGAN TO TAKE DUODOPA AT THE SIDE PORT OF THE Y CONNECTOR AND PERIODICALLY RINSED THE DEVICE. THE PATIENT WAS GIVEN AN X-RAY AND THE INTESTINAL TUBE WAS FOUND TO BE DISLOCATED AND KINKED WITHIN THE STOMACH. THIS INTESTINAL TUBE WAS REMOVED ON (B)(6), 2010 AND THE PROCEDURE WAS COMPLETED WITH AN 80CM ENDOVIVE TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED: THE TUBE WAS PLACED ON (B)(6), 2009, THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. CORRECTION TO THE INFORMATION: THE TUBE WAS REMOVED AND EXCHANGED ON (B)(6), 2010.

    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 Other MADOPARK Q| DUODOPA