BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? STANDARD PEG KIT

    MDR report key: 3653886 · Received February 28, 2014

    Report

    Report Number
    3005099803-2014-01209
    Event Type
    Injury
    Date Received
    February 28, 2014
    Date of Event
    January 29, 2014
    Report Date
    February 5, 2014
    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 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 STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PEG TUBE WAS REMOVED FROM THE PATIENT DUE TO ACUTE BURIED BUMPER SYNDROME. IT WAS ALSO REPORTED THAT THE PATIENT HAD FLUID DISCHARGE AND INFECTION ON THE CATHETER SITE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE STANDARD PEG KIT PULL METHOD WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PEG TUBE WAS REMOVED FROM THE PATIENT DUE TO ACUTE BURIED BUMPER SYNDROME. IT WAS ALSO REPORTED THAT THE PATIENT HAD FLUID DISCHARGE AND INFECTION ON THE CATHETER SITE. 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. ADDITIONAL INFORMATION RECEIVED ON APRIL 13, 2014: THE EVENT DATE IS (B)(6), 2014. THE PATIENT'S FIRST PEG KIT DEVICE WAS PLACED ON (B)(6), 2013. THE NAME OF THE PROCEDURE WAS PEG-J PLACEMENT WITH ENDOSCOPY. THE ANATOMY LOCATION INVOLVED IS THE TREITZ LIGAMENT. A NEW PEG TUBE WAS NOT PLACED AND THE DUODOPA WAS DISCONTINUED. THE PATIENT'S CONDITION WAS GOOD. THE PATIENT WAS HOSPITALIZED AND THERE WAS ADMINISTRATION OF IV ANTIBIOTIC TREATMENT (TREATMENT NAME WAS NOT KNOWN-8 DAYS 2X 200 MG). PATIENT DOES NOT HAVE ANY OTHER MEDICAL CONDITION BESIDES PARKINSON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123685 ENDOVIVE? STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568380 15910657

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other DUODOPA