BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE SAFETY PEG KITS PULL METHOD

    MDR report key: 1222913 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06117
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K031538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON THE EVENT DATE, THAT A ENDOVIVE SAFETY PEG KITS PULL METHOD WAS PLACED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE THREE MONTHS PRIOR. ACCORDING TO THE COMPLAINANT, IN 2008, THE TUBE WAS FOUND TO HAVE A CRACK OUTSIDE THE PT'S BODY AT ABOUT 3 OR 4 CENTIMETERS FROM THE BOLSTER AND LEAKAGE WAS FOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE (DEVICE UNK). NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE SAFETY PEG KITS PULL METHOD KNT BOSTON SCIENTIFIC CORPORATION M00566521 11258813

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK