BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THROMBUSTER II

    MDR report key: 2806683 · Received October 23, 2012

    Report

    Report Number
    9614654-2012-00003
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 23, 2012
    Manufacturer
    KANEKA CORPORATION
    Product Code
    DXE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE CONCERNED "THROMBUSSTER II" HAS NEVER DISTRIBUTED IN US, HOWEVER, IS A SIMILAR DEVICE WITH "XPRESS-WAY RX EXTRACTION CATHETER" DISTRIBUTED IN US UNDER 510(K) # K101839. THE STRUCTURE OF THE ASPIRATION LUMEN IS DIFFERENT WITH EACH OTHER. THE ACTUAL PRODUCT 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 DISTAL TIP, WHICH IS PROBABLY STILL REMAINED IN THE PT'S VESSEL, WAS NOT INCLUDED IN THE RETURNED PRODUCT AND NOT AVAILABLE FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD (DHR) OF THROMBUSTER II WITH LOT NUMBER KP082052 IN WHICH THE CONCERNED INDIVIDUAL DEVICE IS INCLUDED, WAS REVIEWED AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN ITS MFG PROCESSES. THE DEVICE MET ITS MATERIAL, ASSEMBLING AND PRODUCT SPECIFICATIONS. IT WAS REPORTED THAT THE PHYSICIAN FELT A STRONG RESISTANCE WHEN THE DISTAL TIP OF THE THROMBUSTER II CAME CLOSE TO THE ORIFICE OF THE GUIDING CATHETER (GC), AND THE DEVICE WAS FORCED TO PULL OUT OF THE PT. AS A POSSIBLE CAUSE, WE SPECULATE AS FOLLOWS: IT MIGHT BE 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 THROUGH THE GC, SO THAT THE DEVICE WAS STUCK WITH THE GC. SUCH THE 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

    AFTER PLACING A DRUG ELUTING STENT IN RCA #3 (80% STENOSIS WITH NO CALCIFICATION), THE FLOW DETERIORATED AND THIS DEVICE (THROMBUSTER II) WAS EMPLOYED FOR THROMBUS ASPIRATION. WHEN THE DEVICE WAS TRIED TO PULL BACK AFTER THE THROMBUS ASPIRATION PROCEDURE, THE GUIDING CATHETER (GC) WITH THE DEVICE JUMPED AT THE ORIFICE OF THE CORONARY ARTERY. THE PHYSICIAN FELT A STRONG RESISTANCE WHEN THE DISTAL TIP OF THE DEVICE CAME CLOSE TO THE ORIFICE OF THE GC. WHEN THE DEVICE WAS FORCED TO PULL OUT OF THE PT, THE DISTAL TIP OF THE DEVICE WAS FOUND SHEARED OFF. THE PHYSICIAN TRIED TO LOCATE THE LOST DISTAL TIP BY USING X-RAY CINE-SCOPE, BUT IT WAS NOT FOUND IN THE PT'S CORONARY REGION. SINCE NO RELEVANT SYMPTOM WAS OBSERVED ON THE PT, NO INTERVENTION TO TAKE OUT THE TIP, POSSIBLY REMAINING IN THE PT'S VESSELS, WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THROMBUSTER II THROMBUS ASPIRATION CATHETER DXE KANEKA CORPORATION KP082052

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention COOK GUIDING CATHETER 7FR