BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON XPANDER II EU

    MDR report key: 3931651 · Received July 14, 2014

    Report

    Report Number
    2953769-2014-00092
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    October 6, 2014
    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

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT DURING FUNCTIONAL ANALYSIS IT WAS NOT MORE POSSIBLE TO INFLATE THE BALLOON DUE TO A LEAKAGE FROM THE END OF THE DISTAL BONDING. VISUAL ANALYSIS CONFIRMED THAT THE LEAKAGE COMES FROM A HOLE IN THE INNER SHAFT, DUE TO STYLET RE-INSERTION IN THE IBT WHEN THE SHAFT WAS NOT STRAIGHT. BASED ON THE INFORMATION PROVIDED, VISUAL AND FUNCTIONAL ANALYSIS THE MOST PROBABLE ROOT CAUSE OF THE LEAKAGE OF THE IBT COMES FROM A HOLE IN THE INNER SHAFT CREATED BY THE RE-INSERTION OF THE STYLET WHEN THE IBT WAS NOT STRAIGHT ENOUGH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN BALLOON KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOONS RUPTURED WHILE INFLATING. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410416 KYPHON XPANDER II EU ARTHROSCOPE HRX KYPHON NEUCHATEL 0007082895

    Patients

    Seq Age Sex Outcome Treatment
    1