BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO CUBBY DUAL PORT STANDARD BALLOON

    MDR report key: 1230752 · Received October 28, 2008

    Report

    Report Number
    3005099803-2008-05520
    Event Type
    Malfunction
    Date Received
    October 28, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 1, 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

    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 CORP, THAT DURING PLACEMENT OF A CORFLO CUBBY DUAL PORT STANDARD BALLOON IN 2008, THE BALLOON WOULD NOT INFLATE AFTER IT HAD BEEN INSERTED. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED USING ANOTHER CORFLO CUBBY DUAL PORT STANDARD BALLOON DEVICE. NO PT COMPLICATIONS WERE 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 DUAL PORT STANDARD BALLOON KNT BOSTON SCIENTIFIC CORPORATION M00581400 0000030142

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK