BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 14 LP LOW PROFILE PTA BALLOON DIALATATION CATHETER

    MDR report key: 1962831 · Received January 12, 2011

    Report

    Report Number
    1820334-2011-00025
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 14, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K090822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    PRODUCT WAS USED TO DILATE A STENOSIS. EVERYTHING SEEMED TO BE OK, WHEN RETRACTING THE PRODUCT NO RESISTANCE WAS FELT. PRODUCT WAS PLACED ASIDE FOR POSSIBLE REUSE DURING THE PROCEDURE. WHILE PROCEEDING WITH ANOTHER CATHETER RESISTANCE WAS FELT. PART OF THE BALLOON WAS DISCOVERED (UNDER FLUOROSCOPY). AFTER CHECKING THE REMAINS ON THE TABLE, THE LOST PART INSIDE THE PATIENT'S VESSEL WAS RETRIEVED WITH A SNARE. NO PARTS WERE LEFT BEHIND. PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 14 LP LOW PROFILE PTA BALLOON DIALATATION CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA F2544071

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention