BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE SAFETY PEG KITS PULL METHOD

    MDR report key: 1160025 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04501
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT AN ENDOVIVE SAFETY PEG KIT DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PLACEMENT PROCEDURE PERFORMED SIX DAYS PRIOR. ACCORDING TO THE COMPLAINANT, THE INSERTION WIRE WAS NOT IN THE PACKAGE DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER ENDOVIVE SAFETY PEG KIT DEVICE. NO PATIENT COMPILATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE SAFETY PEG KITS PULL METHOD KNT BOSTON SCIENTIFIC CORPORATION M00566720 11803317

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK