BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPANDER II

    MDR report key: 2941575 · Received February 4, 2013

    Report

    Report Number
    2953769-2013-00018
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    February 21, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    K101864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE BALLOON HAS BEEN AT LEAST INFLATED ONE TIME WITH CONTRAST LIQUID, BECAUSE THERE ARE PARTICLES OF DRIED CONTRAST LIQUID IN THE BALLOON. PRESENCE OF BLOOD INDICATES THAT THE BALLOON HAS BEEN USED DURING SURGERY. FUNCTIONAL ANALYSIS HAS BEEN DONE. THE FIRST ATTEMPT TO INFLATE THE BALLOON HAS BEEN DONE WITH A LOCKING SYRINGE AND WAS NOT POSSIBLE BECAUSE THE CATHETER SEEMS TO BE BLOCKED. ANOTHER ATTEMPT TO INFLATE THE BALLOON HAS BEEN DONE WITH AN INFLATION SYRINGE. THE PRESSURE WAS MAINTAINED AT ABOUT 600 PSI FOR APPROXIMATELY 30 SECOND TO UNBLOCK THE CATHETER. AT THIS MOMENT, A LEAKAGE WAS VISIBLE NEARBY THE MIDDLE OF THE BALLOON. BASED ON THE INFORMATION PROVIDED, VISUAL AND FUNCTIONAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE LEAKAGE OF THE BALLOON IS ATTRIBUTED TO THE CONTACT WITH BONE SPLINTERS AND/OR SURGICAL TOOLS DURING SURGERY. NOTE THAT IT WAS REPORTED THAT THIS WAS AN OSTEOPOROTIC FRACTURE AND IN THIS CASE, CONTACT WITH SHARP BONE ARE THE MOST PROBABLE ROOT CAUSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE. DURING INFLATION, IT WAS REPORTED THAT THE BALLOON RUPTURED. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46173 XPANDER II ARTHROSCOPE HRX KYPHON NEUCHATEL 0006177341

    Patients

    Seq Age Sex Outcome Treatment
    1