BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE 3S LOW PROFILE BALLOON KIT

    MDR report key: 5380938 · Received January 20, 2016

    Report

    Report Number
    2025851-2016-00010
    Event Type
    Malfunction
    Date Received
    January 20, 2016
    Report Date
    December 22, 2015
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    PIF
    PMA / PMN Number
    K142297
    Removal / Correction Number
    2025851-1/7/16-001-R
    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. SPECIFIC EVENT DATE IS NOT KNOWN OTHER THAN IT WOULD BE SUBSEQUENT TO THE IMPLANT DATE PROVIDED IN THIS REPORT. XERIDIEM (LEGAL MANUFACTURER) PART NUMBER IS 70-0050-414; (B)(4) PART NUMBER IS M00548370; THE BOSTON SCIENTIFIC PART NUMBER IS THE ONE APPEARING ON THE DEVICE LABEL. 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 BOSTON SCIENTIFIC. THE DEVICE WAS NOT ABLE TO BE RETURNED FOR EVALUATION SO A DEFINITE CAUSE FOR THIS PARTICULAR DEVICE COULD NOT BE DETERMINED. 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. DEVICE WAS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    FLUID LEAKAGE FROM THE BALLOON DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39547 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