BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPANDER, 15/3 IBT

    MDR report key: 3357640 · Received September 19, 2013

    Report

    Report Number
    2953769-2013-00141
    Event Type
    Malfunction
    Date Received
    September 19, 2013
    Date of Event
    August 16, 2013
    Report Date
    August 22, 2013
    Manufacturer
    MDT KYPHON NEUCHATEL MFG
    Product Code
    HRX
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FIRST VISUAL ANALYSIS OF THE IBT (AS RECEIVED) HAS BEEN DONE. THE SHAPE OF THE BALLOON INDICATES THAT IT HAS BEEN INFLATED AT LEAST ONE TIME, BUT PROBABLY UNDER LOW PRESSURE. DURING FUNCTIONAL ANALYSIS THE IBT WAS PREPARED AS PER A NORMAL MIV (MAXIMUM INFLATION VOLUME). THEN A KIS SYRINGE WAS PREPARED AND THE BALLOON HAS BEEN INFLATED TO ITS MIV VALUE OF 4CC WITH WATER. THE PRESSURE HAS BEEN MAINTAINED DURING 5 MINUTES. AFTER 5 MINUTES, A VISUAL ANALYSIS INDICATES THAT THERE IS NO LEAKAGE OF THE BALLOON OR OTHER PART OF THE IBT. NO OTHER DAMAGE HAS BEEN OBSERVED ON THE IBT. BASED ON THE INFORMATION PROVIDED, VISUAL AND FUNCTIONAL ANALYSIS, THE REPORTED EVENT OF A BALLOON PUNCTURE CANNOT BE CONFIRMED. THE IBT FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, FOUR BALLOONS PRESENTED WITH A PUNCTURE/RUPTURE IN THE TIP THUS PREVENTING THEM FROM INFLATING. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473124 XPANDER, 15/3 IBT ARTHROSCOPE HRX MDT KYPHON NEUCHATEL MFG 0006658090

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR