BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT

    MDR report key: 3031557 · Received April 2, 2013

    Report

    Report Number
    3005099803-2013-02133
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. 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 ENDOVIVE INITIAL PEG PLACEMENT KIT WAS PLACED. THE PROCEDURE DATE IS UNKNOWN. IT WAS REPORTED IN EARLY FEBRUARY THERE WAS INFLAMMATORY INDURATION AROUND THE ORIFICE OF THE GASTROJEJUNOSTOMY WITH PAIN. AN ULTRASOUND SHOWED TUBING WRAPPED IN SOFT TISSUE (COLLAR BETWEEN THE SKIN AND THE STOMACH WALL). ON (B)(6) 2013 REPORTED E. FAECALIS INFECTION AROUND THE STOMA. OUTSOURCING OF THE TUBE WAS REPORTED ON (B)(6) 2013. A NEW ENDOVIVE INITIAL PEG PLACEMENT KIT WAS PLACED. 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
    135272 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK518

    Patients

    Seq Age Sex Outcome Treatment
    1 Other CONTRAMAL| INEXIUM| DOLIPRANE| LÉPONEX| FORLAX| DUODOPA| VALIUM| DOMPÉRIDONE