BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1170629 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04613
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 18, 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 UNK. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF, AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP ON AUGUST 18, 2008, THAT A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) PROCEDURE PERFORMED IN 2008. ACCORDING TO THE COMPLAINANT, THE LOCKING LAB OF THE RIGHT ANGLE FEEDING TUBE WAS DAMAGED 4 DAYS AFTER PLACEMENT AND WAS UNABLE TO LOCK. THE PROCEDURE WAS COMPLETED WITH ANOTHER CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'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 M00581510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK