BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY DUAL PORT STANDARD BALLOON

    MDR report key: 1062025 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00720
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 6, 2008
    Report Date
    May 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    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 UNKNOWN. THE SUSPECT DEVICE HAS NOT BEEN RETURNED; THEREFORE, A DEVICE EVALUATION HAS NOT BEEN PERFORMED. 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 DUAL PORT STANDARD BALLOON DEVICE WAS USED DURING A PERCUTANEOUS ENDOSCOPIC GASTROSTOMY REPLACE PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE "THE BALLOON RUPTURED". NO REMNENTS REMAINED IN THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE, MANUFACTURE AND PRODUCT UNKNOWN. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORFLO CUBBY DUAL PORT STANDARD BALLOON KNT BOSTON SCIENTIFIC CORPORATION M00581420 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK