BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE STANDARD PEG KITS PULL METHOD

    MDR report key: 1102025 · Received August 7, 2008

    Report

    Report Number
    3005099803-2008-01525
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS DISCARDED. A DEVICE ANALYSIS CANNOT BE PERFORMED, THEREFORE, THE CAUSE OF THE REPORTED IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A REVIEW OF THE COMPLAINT DATABASE REVEALED THAT ONE ADDITIONAL COMPLAINT HAS BEEN REPORTED FOR THIS LOT (FROM THE SAME CUSTOMER, FOR THE SAME FAILURE, IN A DIFFERENT PATIENT).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 11, 2008 THAT A ENDOVIVE STANDARD PEG KIT PULL METHOD DEVICE WAS USED DURING A PEG TUBE PLACEMENT PROCEDURE IN A FEMALE PATIENT IN 2008. ACCORDING TO THE COMPLAINANT, "THE PULL WIRE BROKE." THE PHYSICIAN USED A HEMOSTAT (MANUFACTURER UNKNOWN) TO PULL THE REMAINDER OF THE WIRE TO COMPLETE THE PROCEDURE. 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 KITS PULL METHOD KNT BOSTON SCIENTIFIC CORPORATION M00568201 11733951

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK