BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THROMBUSTER II

    MDR report key: 8255618 · Received January 16, 2019

    Report

    Report Number
    3009761573-2018-00022
    Event Type
    Injury
    Date Received
    January 16, 2019
    Date of Event
    December 18, 2018
    Report Date
    December 19, 2018
    Manufacturer
    KANEKA CORPORATION
    Product Code
    DXE
    PMA / PMN Number
    K101839
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WERE REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE VISUAL TEST (INCLUDING THE WELDED PART OF THE DISTAL TIP) AND THE INTERNAL DIAMETER MEASUREMENT OF GW LUMEN FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE WITHSTAND ABSORPTION PRESSURE TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. THE ACTUAL DEVICE CONCERNED WAS RETURNED AND INVESTIGATED: THE DISTAL TIP (GW LUMEN SHAFT) WAS TORN OFF FROM THE CATHETER SHAFT (SUCTION LUMEN SHAFT). MANY SMALL AXIAL SCRATCHES WERE OBSERVED ON THE SURFACE OF THE CATHETER SHAFT (ESPECIALLY, UNTIL THE 30 MM FROM THE DISTAL). NO PARTICULAR DAMAGE OR ABNORMAL FEATURE WAS OBSERVED ON THE OTHER PARTS. PROBABLE CAUSE(S) AND OUR COMMENT: WHEN THE CATHETER WAS REMOVED, THE DISTAL TIP WAS TRAPPED IN THE HIGHLY CALCIFIED CTO LESIONS. (AT THIS TIME, THE SMALL AXIAL SCRATCHES ON THE CATHETER SHAFT WERE OCCURED). FURTHER ATTEMPT WAS MADE TO PULL OUT THE DEVICE FORCIBLY WHILE THE DISTAL PORTION WAS TRAPPED IN THE LESION. THEN THE DISTAL TIP TRAPPED IN THE LESION WAS RIPPED AWAY FROM THE SHAFT. THIS SITUATION MAY HAPPEN WHEN OPERATORS TRY TO PULL THE THROMBUSTER II INTO A GC (OR A SHEATH DEVICE) TOO QUICKLY AND/OR STRONGLY. WE BELIEVE THE REPORTED EVENT WAS CAUSED BY NOT A DEFECT OR MALFUNCTION OF THE DEVICE BUT BY A DEVICE HANDLING ISSUE.

    Description of Event or Problem · 1

    THE DEVICE CONCERNED "THROMBUSTER II" WHICH HAS NEVER DISTRIBUTED IN US IS SIMILAR TO "XPRESS-WAY RX" DISTRIBUTED IN US UNDER 510(K) # K101839. THE STRUCTURE OF THE ASPIRATION LUMEN IS DIFFERENT FROM EACH OTHER. THE THROMBUSTER II WAS APPROACHED FROM ABOVE KNEE (AK) TO HIGHLY CALCIFIED CTO LESIONS OF THE ANTERIOR TIBIAL ARTERY (ATA). AFTER THE THROMBUS ASPIRATION, THE PHYSICIAN HAD A FEELING OF STRANGENESS WHILE THE CATHETER WAS REMOVED AND NOTICED THAT THERE WAS NO DISTAL PART OF THE CATHETER. THE BROKEN DISTAL TIP WAS RETRIEVED THROUGH THE SHEATH BY PUSHING IT UP USING COYOTE BALLOON DILATATION CATHETER (BOSTON SCIENTIFIC, 2.0 MM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44612 THROMBUSTER II CATHETER, EMBOLECTOMY DXE KANEKA CORPORATION KP098143

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention