BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBUSTER II

    MDR report key: 3772681 · Received March 17, 2014

    Report

    Report Number
    9614654-2014-00005
    Event Type
    Malfunction
    Date Received
    March 17, 2014
    Date of Event
    January 31, 2014
    Report Date
    March 17, 2014
    Manufacturer
    KANEKA CORPORATION
    Product Code
    MMY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE CONCERNED "THROMBUSTER II" HAS NEVER DISTRIBUTED IN U.S., HOWEVER, IS A SIMILAR DEVICE WITH "XPRESS-WAY RX EXTRACTION CATHETER" DISTRIBUTED IN U.S. UNDER 510(K) NUMBER K101839. THE STRUCTURE OF THE ASPIRATION LUMEN IS DIFFERENT WITH EACH OTHER. THE ACTUAL PRODUCT USED WAS NOT RETURNED FOR OUR FURTHER INVESTIGATION. THE DEVICE HISTORY RECORD (DHR) OF THROMBUSTER II WITH LOT NUMBER KP093063 WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN ITS MANUFACTURING PROCESSES. THE DEVICE MET ITS MATERIAL, ASSEMBLING AND PRODUCT SPECIFICATIONS. AS A POSSIBLE CAUSE, WE SPECULATE AS FOLLOWS: THE GUIDE-WIRE (GW) FORMED A LOOP OR A BEND IN THE SPACE BETWEEN THE PROXIMAL END OF THE GUIDE-WIRE LUMEN OF THE DEVICE AND THE ORIFICE OF THE GC, WHILE RETRIEVING THE DEVICE THROUGH THE GC, SO THAT THE DEVICE WAS STUCK WITH THE GC. SUCH THE SITUATION MAY HAPPEN WHEN THE DEVICE IS RETRIEVED INTO A GC TOO QUICKLY AND/OR TOO STRONGLY. WHILE THE DISTAL TIP OF THE DEVICE WAS UNABLE TO ENTER INTO THE GC WITH A PART OF THE GW BENT OUTSIDE THE GC AND THE GW-LUMENE (INSIDE THE DISTAL TIP), THE SHAFT OF THE DISTAL TIP SHEARED OFF WITH THE GW BY FORCIBLY RETRIEVING THE DEVICE OUT OF THE VESSEL.

    Description of Event or Problem · 1

    THIS DEVICE (THROMBUSTER II) WAS EMPLOYED FOR A THROMBUS ASPIRATION IN PERONEAL ARTERY. WHEN THE DEVICE WAS TRIED TO RETRIEVE OUT OF THE VESSEL AFTER THE THROMBUS ASPIRATION, THE DISTAL TIP OF THE DEVICE WAS SHEARED OFF AND REMAINED ON THE GUIDE-WIRE (GW) IN THE VESSEL. THE PHYSICIAN INSERTED A NEW GW AND ROTATED TO ENTANGLE WITH THE ORIGINAL GW, AND SUCCESSFULLY REMOVE THE DISTAL OUT OF THE VESSELS TOGETHER WITH THE GWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157122 THROMBUSTER II THROMBUS ASPIRATION CATHETER MMY KANEKA CORPORATION KP093063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention