BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE SAFETY PEG KIT

    MDR report key: 1221209 · Received November 5, 2008

    Report

    Report Number
    3005099803-2008-06068
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO MALFUNCTIONS THAT OCCURRED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE TIP OF AN ENDOVIVE SAFETY PEG TUBE DETACHED AS IT WAS BEING PULLED THROUGH THE PATIENT'S ABDOMEN (PATIENT AGE, GENDER AND WEIGHT UNKNOWN). ACCORDING TO THE COMPLAINANT, THE TIP WAS NOT LEFT IN THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER ENDOVIVE SAFETY PEG KIT DEVICE. REFER TO MANUFACTURER'S REPORT #3005099803-2008-06069 FOR THE DETAILS REGARDING THE SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE SAFETY PEG KIT KNT BOSTON SCIENTIFIC CORPORATION M00566470 11952977

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other