BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE STANDARD PEG KIT PULL METHOD

    MDR report key: 1070414 · Received July 3, 2008

    Report

    Report Number
    3005099803-2008-01074
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DATE OF MANUFACTURE CANNOT BE DETERMINED. THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. THE 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THE A 24FR SAFETY PEG PULL (W/AMPULE) DEVICE WAS USED DURING A PEG PLACEMENT PROCEDURE. 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 SAFETY SCALPEL.

    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 UNK