BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

    MDR report key: 3902920 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02371
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 4, 2014
    Report Date
    June 9, 2014
    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 PATIENT'S EXACT DATE OF BIRTH IS UNKNOWN HOWEVER, THE PATIENT WAS BORN IN 1935.

    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 KINKED. 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 TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON¿S DISEASE. DATE OF JEJUNAL TUBE PLACEMENT IS UNKNOWN. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE JEJUNAL TUBE WAS KINKED. 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. DATE OF JEJUNAL TUBE PLACEMENT IS UNKNOWN. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2014, THE JEJUNAL TUBE WAS KINKED. 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 OCTOBER 29, 2014: PROCEDURE DATE IS (B)(6) 2012. THE JEJUNAL TUBE WAS REPLACED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379387 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK443

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other DUODOPA