BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 2031737 · Received February 25, 2011

    Report

    Report Number
    1820334-2011-00097
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 27, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DQY
    PMA / PMN Number
    K091527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED. RUPTURE IS ADDRESSED IN THE IFU. THE DEVICE WAS RETURNED IN A USED AND DAMAGED CONDITION. PER DESIGN FAILURE MODES EFFECTS ASSOCIATION (DFMEA), BALLOON BURST, COMPLIANCE, AND FATIGUE VERIFICATION TESTING PERFORMED. THE RBP OF 11 ATM IS DOCUMENTED IN THE IFU AND LABEL. THE DEVICE IS INSPECTED TO ENSURE BALLOON IS UNDAMAGED. BURST TESTS ARE PERFORMED, A MINIMUM OF 10 BALLOONS PER LOT. EACH DEVICE IS LEAK TESTED AND THE BALLOON BONDS ARE EXAMINED. EACH DEVICE IS SHIPPED WITH AN IFU THAT DELINEATES THE PROPER INFLATION AND DEFLATION PROCEDURES. THESE DETECTION ACTIVITIES WILL LIKELY RESULT IN A VERY HIGH PROBABILITY OF DETECTION TO PREVENT RUPTURE. THE DEVICE WAS RETURNED INSIDE THE SHEATH. THE TIP OF THE BALLOON CATHETER WAS ELONGATED AND SEPARATED DISTAL TO THE PROXIMAL BALLOON BOND. IT WAS ALSO NOTED THAT THE TIP WAS ELONGATED. THE SEPARATED TIP FRAGMENT WAS RETURNED WITH THE BALLOON MATERIAL ATTACHED AND FOLDED BACKWARDS TOWARD THE DISTAL BALLOON BOND. THE TIP OF THE SHEATH WAS DAMAGED. THE CONDITION OF THE RETURNED DEVICE SUGGESTS THE BALLOON RUPTURED LONGITUDINALLY AND TORE CIRCUMFERENTIALLY AT A POINT OF CONSTRICTION. THE CUSTOMER REPORTED REMOVING THE SHEATH AND DEVICE AS A UNIT. BASED ON THE CONDITION OF THE RETURNED PRODUCT AND THE INFORMATION PROVIDED, IT IS UNKNOWN WHEN THE TIP SEPARATED. THE RBP OF THE BALLOON IS 11 ATM. THE PRESSURE AT RUPTURE IS UNKNOWN AS A 3CC SYRINGE WAS USED TO INFLATE THE BALLOON. IFU WARNS TO NOT EXCEED THE RATED BURST PRESSURE. USE OF A PRESSURE GAUGE IS RECOMMENDED. LESION MORPHOLOGY AND/OR OVER-INFLATION MAY CONTRIBUTE TO BALLOON RUPTURE. REVIEW OF THE MANUFACTURING RECORDS WAS UNREMARKABLE. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ANALYSIS (QE RA).

    Description of Event or Problem · 1

    DURING INFLATION, THE BALLOON RUPTURED-CIRCUMFERENTIALLY. NO INFLATION DEVICE WAS USED FOR INFLATION; THE CUSTOMER USED A 3CC SYRINGE. 50/50 SALINE/CONTRAST MEDIA WAS USED TO INFLATE THE BALLOON. AFTER THE DIFFICULTY OCCURRED, THE BALLOON AND SHEATH WERE REMOVED FROM THE PATIENT; HOWEVER, COULD NOT GET BALLOON THROUGH SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER BALLOON FROM A COMPETITOR. NO HARM TO THE PATIENT WAS REPORTED. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK, INC. NA 2588749

    Patients

    Seq Age Sex Outcome Treatment
    1