BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPANDER IBT

    MDR report key: 2893532 · Received January 2, 2013

    Report

    Report Number
    2953769-2013-00001
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 27, 2012
    Report Date
    February 20, 2013
    Manufacturer
    KYPHON NEUCHATEL
    Product Code
    HRX
    PMA / PMN Number
    K041454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE RETURNED DEVICE SHOWS THAT DURING FUNCTIONAL ANALYSIS, A FIRST ATTEMPT HAS BEEN PERFORMED TO INFLATE THE BALLOON WITH 4CC OF WATER WITH A KIS A08E SYRINGE. AT THIS POINT, THE IBT SEEM TO LEAK FROM THE DISTAL BONDING. A SECOND ATTEMPT HAS BEEN PERFORMED WITH 4CC AND A KIS SYRINGE, BUT SLOWER. THE BALLOON APPEARS TO HAVE A LEAKAGE FROM THE INNER PART OF THE INNER MIX AT THE DISTAL BONDING. NOTE THAT THE DISTAL BONDING HAS BEEN ANALYZED AND NO PROBLEM HAS BEEN FOUND BETWEEN THE DIFFERENT LAYERS. VISUAL ANALYSIS SHOWS THAT THE IBT HAS BEEN STRONGLY DEFORMED DURING THE INTERVENTION. THE OUTERSHAFT HAS BEEN EXTENDED. NORMALLY, WHEN THE STYLET IS SCREWED ON THE IBT, IT IS ALMOST LONG AS THE IBT AND THIS IS NOT THE CASE HERE. MEASUREMENT OF THE OUTER DIAMETER OF THE OUTERSHAFT HAS BEEN TAKEN AND IT SHOWS THAT THE OUTERSHAFT HAS BEEN PLASTICALLY DEFORMED. THE PROXIMAL BONDING HAS ALSO BEEN ANALYZED AND A MARK IS VISIBLE ON THE PROXIMAL BONDING OF THE IBT. BASED ON THE INFORMATION PROVIDED, FUNCTIONAL AND VISUAL ANALYSIS, THE MOST PROBABLE ROOT CAUSE OF THE DEFLATION ISSUE COULD NOT BE FOUND BECAUSE OF THE DEGRADATION STATE OF THE IBT. IT HAS BEEN DETERMINED THAT THE IBT HAVE BEEN STRONGLY DEFORMED BY THE SURGEON DURING THE SURGERY, PROBABLY BECAUSE THE BALLOON COULD NOT GO OUT OF THE CANNULA.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). LOCATION: HOSPITAL. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT AFTER DEFLATION, THE SURGEON WAS NOT ABLE TO REMOVE THE BALLOON. THE BALLOON AND INTRODUCER HAD TO BE REMOVED TOGETHER. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196 XPANDER IBT ARTHROSCOPE HRX KYPHON NEUCHATEL 0006448982

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR