BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2151739 · Received July 6, 2011

    Report

    Report Number
    3005099803-2011-02355
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT HAS BEEN DISPOSED OF; 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 SAFETY PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE LOOP WIRE ATTACHED TO THE END OF THE PEG TUBE BROKE OFF WHEN IT WAS BEING PULLED THROUGH THE PATIENT'S STOMACH. THE PEG WAS REMOVED BY HAND FROM THE PATIENT'S MOUTH. WHILE ATTEMPTING TO PLACE A NEW SAFETY PEG KIT PULL METHOD THE PHYSICIAN COULD NOT OBTAIN VISUALIZATION THEREFORE, A NEW DEVICE WAS NOT PLACED. THE LACK OF VISUALIZATION WAS NOT RELATED TO THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566720 14217694

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR