BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1200115 · Received October 15, 2008

    Report

    Report Number
    3005099803-2008-05291
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 16, 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

    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 CORPORATION IN 2008 THAT A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS USED FOR A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PROCEDURE. ACCORDING TO THE COMPLAINANT, SEVERAL DAYS AFTER PLACEMENT, THE RIGHT ANGLE FEEDING TUBE OF THE GASTROSTOMY DEVICE WAS NOTED TO BE BROKEN AND THE Y-PORT HAD DETACHED FROM THE FEEDING TUBE. THE DEVICE WAS REPLACED WITH ANOTHER CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE. THERE WERE NO PT 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 M00581310 0000026124

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK