BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, RIGHT ANGLE BOLSTER, 20FR

    MDR report key: 5961638 · Received September 19, 2016

    Report

    Report Number
    2025851-2016-00015
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    July 8, 2016
    Report Date
    July 9, 2016
    Manufacturer
    XERIDIEM MEDICAL DEVICES
    Product Code
    KNT
    UDI-DI
    00813939020045
    PMA / PMN Number
    K083684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    XERIDIEM (LEGAL MANUFACTURER) PART NUMBER IS 70-0023-020; (B)(4) (EXCLUSIVE DISTRIBUTOR) PART NUMBER IS M00582150; THE(B)(4) PART NUMBER IS THE ONE APPEARING ON THE LABEL. THE DEVICE WAS NOT ABLE TO BE RETURNED FOR EVALUATION. INSTRUCTIONS FOR USE WARNINGS INCLUDE ONE THAT INDICATE THE DEVICE IS FOR SINGLE USE ONLY. SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION, A DEFINITE ROOT CAUSE FOR THIS DEVICE'S FAILURE COULD NOT BE DETERMINED. THE PROCESS FOR MANUFACTURING THIS DEVICE WAS REVIEWED, INCLUDING RECORDS FOR THIS DEVICE'S LOT NUMBER, AND NO NONCONFORMITIES WERE FOUND.

    Description of Event or Problem · 1

    THE DEVICE WAS A REPLACEMENT AND THEY INFLATED THE BALLOON DURING THE PROCEDURE. THEY NOTICED THE NEXT DAY THAT THE PATIENT WAS LETHARGIC OR UNRESPONSIVE. THEY HAD SOME CONCERNS ABOUT THE TUBE BEING DISLODGED. THE PHYSICIAN CAME IN, DEFLATED THE TUBE, REINSERTED IT, REINFLATED IT, AND THEY MOVED THE PATIENT TO THE ICU. THEY STOPPED THE TUBE FEEDING AND HAD A CAT SCAN DONE LATER THAT DAY. IT WAS AFTER THAT POINT THAT THEY NOTICED SOME AIR OR FLUID, SO THEY REMOVED IT AND PUT AIR BACK IN TO REINFLATE THE BALLOON AND PUT IT ON THE TABLE TO WATCH IT AND THE BALLOON DEFLATED. THE BALLOON DEFLATED AND GOT DISLODGE. THE PATIENT WAS TRANSFERRED TO REHAB WITHIN THE HOSPITAL. HOSPITAL TOLD PATIENT'S HUSBAND THAT THE PRODUCT WAS DEFECTIVE, LEAKED AND CAUSED THE PATIENT SERIOUS INJURY. PATIENT IS ON A VENTILATOR, UNRESPONSIVE AND IS NOT IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612391 ENDOVIVE STANDARD BALLOON REPLACEMENT KIT, RIGHT ANGLE BOLSTER, 20FR GASTROSTOMY TUBE KNT XERIDIEM MEDICAL DEVICES 70-0023-020 929301 00813939020045

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention