BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBUSTER II

    MDR report key: 2891339 · Received December 21, 2012

    Report

    Report Number
    9614654-2012-00004
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 21, 2012
    Manufacturer
    KANEKA CORP.
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE CONCERNED "THROMBUSTER II" HAS NEVER BEEN DISTRIBUTED IN THE US; HOWEVER, A SIMILAR DEVICE, "XPRESS-WAY RX EXTRACTION CATHETER" IS DISTRIBUTED IN THE US UNDER 510 (K) #K101839. THE STRUCTURE OF THE ASPIRATION LUMEN IS DIFFERENT WITH EACH OTHER. THE ACTUAL DEVICE USED WAS RETURNED AND INVESTIGATED: THE DISTAL TIP WITH THE GUIDE-WIRE LUMEN WAS SHEARED OFF AND THE ASPIRATION LUMEN (THE CATHETER SHAFT) WHERE THE DISTAL TIP WAS MOUNTED WAS TORN. THE GUIDE-WIRE PORT OF THIS DEVICE WAS FOUND TWISTED AND DEFORMED THAT GOT ROLLED UP. THE DEVICE HISTORY RECORD (DHR) OF THROMBUSTER II WITH LOT NO. KP052153 IN WHICH THE CONCERNED INDIVIDUAL DEVICE IS INCLUDED, WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IT ITS MANUFACTURING PROCESS. THE DEVICE MET ITS MATERIAL, ASSEMBLING AND DEVICE SPECIFICATIONS. AS A POSSIBLE CAUSE, WE SPECULATE AS FOLLOWS: IT MIGHT BE POSSIBLE THAT 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 GUIDING CATHETER (GC), WHILE RETRIEVING THE DEVICE THROUGH THE GC, SO THAT THE DEVICE WAS STUCK IN THE GC. SUCH A SITUATION MAY HAPPEN WHEN THROMBUSTER II IS RETRIEVED INTO A GC TOO QUICKLY AND/OR TOO STRONGLY. AN EXCESSIVE FORCE TO TEAR OFF THE DISTAL TIP FROM THE CATHETER SHAFT WAS GIVEN BY FORCIBLY RETRIEVING THE DEVICE INTO THE GC SO THAT THE DISTAL TIP WAS SHEARED OFF.

    Description of Event or Problem · 1

    THIS DEVICE (THROMBUSTER II) WAS USED TO ASPIRATE THROMBUS IN THE LATERAL BRANCH OF RCA, WHICH EXTENDED AT A STEEP ANGLE. WHEN THE DEVICE WAS TRIED TO RETRIEVE FROM THE PATIENT, THE DISTAL TIP OF THE DEVICE WAS SHEARED OFF AND FLOWED THROUGH THE VESSEL AT THE UPPER ARM. THE PHYSICIAN COLLECTED THE SEPARATED DISTAL TIP BY USING A SNARE DEVICE AND REMOVED OUT OF THE PATIENT. THE PHYSICIAN USED A NEW THROMBUSTER II WITH A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMBUSTER II THROMBUS ASPIRATION CATHETER DXE KANEKA CORP. KP052153

    Patients

    Seq Age Sex Outcome Treatment
    1