BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 2782095 · Received October 3, 2012

    Report

    Report Number
    1820334-2012-00459
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    September 20, 2012
    Report Date
    September 21, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K073378
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NONRESORBABLE MATERIALS, UNRETRIEVED IN BODY IS NOT LISTED IN THE INSTRUCTIONS FOR USE. DEVICE: SEPARATES IS NOT LISTED IN THE INSTRUCTIONS FOR USE. NO PRODUCT WAS RETURNED ASSIST IN THIS INVESTIGATION. BALLOON BURST, COMPLIANCE, AND FATIGUE VERIFICATION TESTING ARE PERFORMED. THE RATED BURST PRESSURE IS DOCUMENTED IN THE INSTRUCTIONS FOR USE (IFU) AND LABEL. THE DEVICE IS INSPECTED TO ENSURE BONDS AND BALLOONS ARE UNDAMAGED. EACH DEVICE IS LEAK TESTED. EACH DEVICE IS SHIPPED WITH IFU THAT DELINEATES THE PROPER INFLATION AND DEFLATION PROCEDURES. WITHOUT THE COMPLAINT DEVICE A THOROUGH ROOT CAUSE ANALYSIS IS NOT POSSIBLE. THE EVENT DESCRIPTION DOES NOT STATE IF IT WAS SUSPECTED THAT THE BALLOON RUPTURED OR SUFFERED SOME OTHER DAMAGE. IN THE ABSENCE OF COMPLAINT DETAIL IT IS DIFFICULT TO DETERMINE FACTORS OTHER THAN PATIENT ANATOMY THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. DUE TO THIS ABSENCE OF DETAIL THE ROOT CAUSE FOR THIS COMPLAINT IS INCONCLUSIVE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ANALYSIS.

    Description of Event or Problem · 1

    THE PHYSICIAN COULD NOT PULL THE BALLOON BACK THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED. THE CUSTOMER STATED THAT A SMALL PIECE OF THE BALLOON MAY STILL BE INSIDE THE PATIENT. HOWEVER, THE CUSTOMER COULD NOT CONFIRM THIS COMMENT. PER CUSTOMER, THE PHYSICIAN HAS NO PLANS TO PERFORM AN ADDITIONAL PROCEDURE TO EXPLORE THE COMMENT THAT A SMALL PIECE OF THE BALLOON MAY BE INSIDE THE PATIENT. PER THE SALES REP, THE PATIENT IS IN STABLE CONDITION AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other