BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE STANDARD PEG KIT PULL METHOD

    MDR report key: 1070398 · Received July 3, 2008

    Report

    Report Number
    3005099803-2008-01080
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Report Date
    June 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE MFR DATE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS IS NOT AVAILABLE; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE MAY 2008 15 MONTH INITIAL G-TUBE ENTERAL FEEDING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    NOTE: DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN ENDOVIVE STANDARD PEG KIT WAS USED DURING A PEG PLACEMENT PROCEDURE (PATIENT AGE, GENDER, AND WEIGHT). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE SAFETY SCALPEL WAS MOVED INTO THE LOCKED POSITION AND COULD NOT BE USED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A SECOND ENDOVIVE STANDARD PEG KIT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE STANDARD PEG KIT PULL METHOD KNT BOSTON SCIENTIFIC CORPORATION M00566481 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1