BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE¿ STANDARD PEG KIT

    MDR report key: 6169811 · Received December 13, 2016

    Report

    Report Number
    3005099803-2016-03831
    Event Type
    Injury
    Date Received
    December 13, 2016
    Date of Event
    December 9, 2015
    Report Date
    November 23, 2016
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    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. (B)(4). 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. THE PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS HOSPITALIZED FOR ALTERATION OF GENERAL STATE, WEIGHT LOSS AND DEGRADATION OF GENERAL STATE DUE TO SUSPICION OF SYSTEM MALFUNCTION. 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 AS OF JANUARY 10, 2017. THE DEVICE WAS REPLACED WITH A NON BSC DEVICE.

    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 PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE PATIENT WAS HOSPITALIZED FOR ALTERATION OF GENERAL STATE, WEIGHT LOSS AND DEGRADATION OF GENERAL STATE DUE TO SUSPICION OF SYSTEM MALFUNCTION. 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
    821511 ENDOVIVE¿ STANDARD PEG KIT TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - COSTA RICA (COYOL) M00568381

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization DUODOPA