BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE 3S LOW PROFILE BALLOON KIT

    MDR report key: 5358586 · Received January 11, 2016

    Report

    Report Number
    2025851-2016-00005
    Event Type
    Malfunction
    Date Received
    January 11, 2016
    Date of Event
    November 25, 2015
    Report Date
    December 8, 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. XERIDIEM (LEGAL MANUFACTURER) PART NUMBER IS 70-0050-516; (B)(4) (EXCLUSIVE DISTRIBUTOR) PART NUMBER IS M00548540; THE (B)(4) 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 (B)(4). THE DEVICE WAS NOT ABLE TO BE RETURNED FOR EVALUATION, SO A DEFINITE CAUSE FOR THE DEVICE INVOLVED WITH THIS REPORT 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

    TWO OF THE DEVICES THAT WERE REPLACED THAT HAD ISSUES WITH LEAKAGE AFTER PLACEMENT (THIS REPORT IS FOR THE SECOND OF THE TWO DEVICES). INCREASED LEAKAGE AND PARENTS DECIDED TO GO BACK TO PREVIOUS BUTTON. THE OTHER ISSUE WITH THE PATIENT IS THAT, THE PATIENT CONTINUES TO KEEP PULLING THE BUTTON OUT AND BURSTING THE BALLOONS. THE PATIENT'S FAMILY SAID, THE BALLOON IS TOO FLEXIBLE AND COMES OUT EASILY. IT WAS PULLED OUT FIVE TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15991 ENDOVIVE 3S LOW PROFILE BALLOON KIT LOW PROFILE BALLOON GASTROSTOMY TUBE PIF XERIDIEM MEDICAL DEVICES 70-0050-516 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1