BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? STANDARD PEG KIT

    MDR report key: 4180662 · Received October 17, 2014

    Report

    Report Number
    3005099803-2014-03422
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 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 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 AS IT IS IMPLANTED IN THE PATIENT; 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. THE EXACT PROCEDURE DATE IS UNKNOWN HOWEVER, THE PEG TUBE WAS IN PLACE FOR 11 MONTHS.ACCORDING TO THE COMPLAINANT, ON (B)(6), 2014, THE PEG TUBE WAS WORN AND HAS BULGES. THE PEG TUBE WAS REPLACED.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
    662675 ENDOVIVE? STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00568381

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other DUODOPA