BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE KIT

    MDR report key: 2123563 · Received June 14, 2011

    Report

    Report Number
    3005099803-2011-01975
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT AGE OF THE PATIENT IS UNKNOWN HOWEVER, THE PATIENT IS OVER 18 YEARS OLD.

    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.

    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 ADVANCED STAGE PARKINSON'S DISEASE. THE DEVICE WAS PLACED IN (B)(6) 2011 (EXACT DAY IS UNKNOWN). ACCORDING TO THE COMPLAINANT, THE J-TUBE BENT 10CM FROM ITS END CAUSING THE TUBE TO OCCLUDE. 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)(6) 2011: THERE WAS NUTRITION AND OTHER MEDICATIONS THAT WERE ADMINISTERED IN ADDITION TO THE DUODOPA. THE EXACT NAMES ARE UNKNOWN. THIS PATIENT HAS SEVERE SWALLOWING DISORDERS.

    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 ADVANCED STAGE PARKINSON'S DISEASE. THE DEVICE WAS PLACED IN (B)(6) 2011 (EXACT DAY IS UNKNOWN). ACCORDING TO THE COMPLAINANT, THE J-TUBE BENT 10CM FROM ITS END CAUSING THE TUBE TO OCCLUDE. 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 13475536

    Patients

    Seq Age Sex Outcome Treatment
    1 DUODOPA