BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE

    MDR report key: 1063047 · Received June 19, 2008

    Report

    Report Number
    3005099803-2008-00798
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 20, 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 NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNK. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED, AND WILL NOT BE RETURNED FOR EVAL. A DEVICE ANALYSIS WILL NOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE APRIL 2008 15-MONTH LOW PROFILE BALLOON ENTERAL FEEDING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY REPLACEMENT PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, "THE BALLOON WAS RUPTURED 3 DAYS AFTER PLACEMENT". REPORTEDLY, THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE WITH ANOTHER LOW PROFILE BALLOON. AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO CUBBY LOW PROFILE GASTROSTOMY DEVICE KNT BOSTON SCIENTIFIC CORPORATION M00581310 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK