BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IKAZUCHI ZERO

    MDR report key: 8694768 · Received June 13, 2019

    Report

    Report Number
    3002808904-2019-00012
    Event Type
    Injury
    Date Received
    June 13, 2019
    Date of Event
    May 16, 2019
    Report Date
    May 21, 2019
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE ACTUAL DEVICE WAS NOT RETUNED, WE INVESTIGATED THE DEVICE HISTORY RECORDS. THE DEVICE HISTORY RECORDS (DHR) OF THE DEVICE CONCERNED WAS REVIEWED: THE PRODUCTION LOT, TO WHICH THE DEVICE CONCERNED BELONGS, PASSED ALL IN-PROCESS INSPECTIONS INCLUDING THE VISUAL TEST, SHAFT PRESSURIZED TEST AND THE BALLOON-WRAPPING TEST FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS INCLUDING THE SHAFT TENSILE STRENGTH TEST AND THE REPETITIVE BALLOON INFLATION/DEFLATION TEST ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. PROBABLE CAUSE(S) AND OUR COMMENT: IT IS INFERRED THAT THE DISTAL TIP FELL OFF BY PULLING THE CATHETER FORCIBLY AFTER THE DISTAL TIP WAS TRAPPED IN THE CALCIFIED LESION.

    Description of Event or Problem · 1

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "IKAZUCHI ZERO", AN RX-TYPE PTCA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NO DISTRIBUTED IN THE US, HOWEVER, WE INTEND TO REPORT THIS CASE AS THE EVENT OCCURRED ON ONE OF THE SIMILAR DEVICES FOR "RX TAKERU PTCA BALLOON DILATATION CATHETER" DISTRIBUTED IN THE US UNDER 510(K) # K163372. WHEN IKAZUCHI ZERO WAS INSERTED INTO THE CALCIFIED LESION, THE DISTAL TIP FELL OFF IN THE CORONARY ARTERY. BECAUSE THERE WAS A RISK OF THROMBOSIS DUE TO THE TIP FELL OFF, THE TIP WAS PRESSED AGAINST THE VESSEL WALL USING A STENT TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488729 IKAZUCHI ZERO CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX KANEKA CORPORATION SP108550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R