BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1161376 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04554
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    PMA / PMN Number
    K990127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED, THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A CORFLO CUBBY LOW PROFILE BALLOON DEVICE WAS PLACED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED APPROXIMATELY ONE MONTH PRIOR. ACCORDING TO THE COMPLAINANT, ABOUT 1 MONTH AFTER PLACEMENT, "NUTRITION LEAKED BETWEEN THE RIGHT ANGLE FEEDING TUBE AND THE LOCKING ADAPTER". IT WAS ALSO REPORTED THAT THE TUBE'S LOCKING TAB WAS BROKEN AND THAT THE LOCKING ADAPTER OF THE BUTTON WAS DAMAGED. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE (PRODUCT AND MANUFACTURER UNKNOWN). THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00581230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK