BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

    MDR report key: 3122771 · Received May 21, 2013

    Report

    Report Number
    3005099803-2013-03994
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    November 27, 2012
    Report Date
    April 25, 2013
    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

    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 JEJUNAL TUBE MIGRATED INTO THE PATIENT¿S BOWELS (B)(4) FOR THE REPORTED EVENT OF STOMA OBSTRUCTION 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 AN ENDOVIVE TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS PLACED. THE PROCEDURE DATE WAS (B)(6) 2011. IT WAS REPORTED THE PATIENT EXPERIENCED ABDOMINAL PAIN AS WELL AS GASTRIC FLOW FROM THE JEJUNAL TUBE ON (B)(6) 2012 AND (B)(6) 2013. ON (B)(6) 2013 THERE WAS A STOMA OBSTRUCTION WHICH WAS RINSED BY THE GASTROENTEROLOGIST. ON (B)(6) 2013 IT WAS NOTED THAT THE EXTREMITY OF THE TUBE WAS STUCK IN THE PATIENT¿S BOWELS. ON (B)(6) 2013 THE EXTREMITY OF THE TUBE WAS FOUND IN THE PATIENT¿S STOOL WHICH CAUSED DIGESTIVE BLEEDING. THE PATIENT WAS TREATED WITH A TRANSFUSION AND PANTOPRAZOLE. PATIENT RECOVERED WITH SEQUELAE. 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 (B)(4) 2013: THE JEJUNAL TUBE THAT WAS STUCK IN THE PATIENT¿S BOWELS AND FOUND IN THE PATIENT¿S STOOL WAS THE PIGTAIL PORTION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS PLACED. THE PROCEDURE DATE WAS (B)(6) 2011. IT WAS REPORTED THE PATIENT EXPERIENCED ABDOMINAL PAIN AS WELL AS GASTRIC FLOW FROM THE JEJUANL TUBE ON (B)(6) 2012 AND (B)(6) 2013. ON (B)(6) 2013, THERE WAS A STOMA OBSTRUCTION WHICH WAS RINSED BY THE GASTROENTEROLOGIST. ON (B)(6) 2013, IT WAS NOTED THAT THE EXTREMITY OF THE TUBE WAS STUCK IN THE PATIENT¿S BOWELS. ON (B)(6) 2013, THE EXTREMITY OF THE TUBE WAS FOUND IN THE PATIENT¿S STOOL WHICH CAUSED DIGESTIVE BLEEDING. THE PATIENT WAS TREATED WITH A TRANSFUSION AND PANTOPROZOLE. PATIENT RECOVERED WITH SEQUELAE. 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
    225072 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK443

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other DUODOPA