BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE 3S LOW PROFILE BALLOON KIT

    MDR report key: 5350750 · Received January 7, 2016

    Report

    Report Number
    2025851-2016-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2016
    Report Date
    December 2, 2015
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    PIF
    PMA / PMN Number
    K142297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION IS NOT AVAILABLE. XERIDIEM (LEGAL MANUFACTURER) PART NUMBER IS 70-0050-414; (B)(4) (EXCLUSIVE DISTRIBUTOR) PART NUMBER IS M00548370; THE (B)(4) PART NUMBER IS THE ONE APPEARING ON THE DEVICE LABEL. BECAUSE THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN, THE EXPIRATION DATE IS ALSO UNKNOWN. XERIDIEM IS LEGAL MANUFACTURER FOR THE DEVICE AND (B)(4) IS OUR EXCLUSIVE DISTRIBUTOR. THEREFORE, THE INITIAL REPORTER TO XERIDIEM IS A PERSON ASSOCIATED WITH (B)(4). EVALUATION OF THE DEVICE ON THIS REPORT WAS NOT POSSIBLE. HOWEVER, A CAPA INVESTIGATION IS IN PROCESS FOR A TREND IN VALVE LEAKAGE. THIS INVESTIGATION IS IN PROCESS BUT APPEARS TO BE POINTING TOWARDS A DESIGN ISSUE WITH THE REFLUX VALVE (DOME VALVE). A RECALL ON THE 70-0050-XXX DEVICES WAS INITIATED ON 12/23/2015. THE REMOVAL REPORT IS PLANNED TO BE SUBMITTED TO FDA AS MANUFACTURER REMOVAL REPORT 2025851-1/7/16-001-R. DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    COMPLAINT WAS REPORTED FOR (B)(6) CHILDREN'S HOSPITAL ((B)(4)) FOR ENDOVIVE 3S LOW-PROFILE ENTERAL FEEDING BALLOON. ON (B)(6) 2015, DR (B)(6) PLACED A 14FR. X 1.7CM (M00548370) FOR AN APPROXIMATELY (B)(6) YEAR OLD MALE PATIENT. THIS WAS THE PATIENT'S FIRST ENTERAL FEEDING REPLACEMENT AFTER SURGERY. IT IS NOT KNOWN HOW MUCH TIME WENT BY FOR THE FAMILY TO NOTICE, OR THEY NOTICED RIGHT AWAY - THEY EXPERIENCED LEAKAGE OF THE GASTRIC CONTENTS OUTSIDE OF THE PATIENT. THE PATIENT WAS SENT HOME WITH MULTIPLE LOW-PROFILE BALLOONS AFTER DR (B)(6) PERFORMED THE PLACEMENT, SO THEY PERFORMED A REPLACEMENT ON THEIR OWN FOR ANOTHER ENDOVIVE 3S OF THE SAME TYPE. THEY AGAIN EXPERIENCED THE SAME ISSUE. DR (B)(6) BELIEVES THAT SOMEHOW THE INTERNAL DIAPHRAGM OF THE BALLOON IS STAYING PROPPED OPEN OR IS NOT DURABLE ENOUGH TO KEEP GASTRIC CONTENTS FROM BEING REFLUXED FROM THE INSIDE THE PATIENT'S STOMACH TO OUTSIDE THE PATIENT. THEY DO NOT EXPERIENCE THIS WHEN THE TAB COVERING IS OVER THE HOLE. HOWEVER, THIS TAB CAN BECOME DISLODGED ON ITS OWN, AND WHEN IT IS NOT COVERED, IT LEAKS AUTOMATICALLY. THE PATIENT'S ENDOVIVE 3S WAS REMOVED BY THE FAMILY AND REPLACED WITH A HALYARD LOW-PROFILE BALLOON, WHICH THE PATIENT HAD BEFORE. DR (B)(6) ASKED THAT WE ADDRESS THIS ISSUE PRIOR TO PERFORMING SUBSEQUENT PLACEMENTS ON OTHER PATIENTS. PATIENT AND LOT NUMBER INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10336 ENDOVIVE 3S LOW PROFILE BALLOON KIT LOW PROFILE BALLOON GASTROSTOMY TUBE PIF XERIDIEM MEDICAL DEVICES 70-0050-414 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1