BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    MDR report key: 9845832 · Received March 17, 2020

    Report

    Report Number
    3002808904-2020-00006
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    February 8, 2020
    Report Date
    February 22, 2020
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "IKAZUCHI ZERO", AN RX-TYPE PTCA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NOT 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. 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 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. RESULTS OF THE INVESTIGATION ON RETURNED CONCERNED DEVICE: WE CONFIRMED THAT THERE WAS NO HOLE OR ABNORMALITY ON THE BALLOON. WHEN PRESSURIZED WITH 6ATM (NOMINAL PRESSURE), THE BALLOON SIZE WAS 2.5MM, AND MET THE SPECIFICATION VALUE. WE CONCLUDED THAT THE FACTORS THAT MAY CONTRIBUTE TO VESSEL DISSECTION OF THE REGION, BUT ARE NOT LIMITED TO, PRESSURE THAT WAS LOADED TO THE BALLOON, INTERACTIONS WITH THE IMPLANTED STENT, AND / OR PATIENT'S ANATOMY.

    Description of Event or Problem · 0

    FROM THE OSTIUM OF THE RCA TO THE DISTAL SEGMENT (BALLOON POSITION) ASSOCIATED VESSEL INCLUDING THE AORTIC ARCH. AFTER FORWARDING THE IKAZUCHI ZERO, THERE IS A DISSECTION OVER THE ENTIRE STRETCH OF LONG-STRETCH STENT IMPLANTATION INCLUDING THE OSTIUM BEFORE DEFLATION OF THE BALLOON.

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "IKAZUCHI ZERO", AN RX-TYPE PTCA BALLOON CATHETER COMPATIBLE WITH 0.014" GUIDEWIRE (GW), IS NOT 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. 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 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. NO DEVICE FAILURES OF THE CONCERNED PRODUCT WAS REPORTED. WE WILL PROCEED THE INVESTIGATION OF CONCERNED PRODUCT ONCE IT IS RETURNED FROM THE DISTRIBUTOR.

    Description of Event or Problem · 1

    FROM THE OSTIUM OF THE RCA TO THE DISTAL SEGMENT (BALLOON POSITION) ASSOCIATED VESSEL INCLUDING THE AORTIC ARCH. AFTER FORWARDING THE IKAZUCHI ZERO, THERE IS A DISSECTION OVER THE ENTIRE STRETCH OF LONG-STRETCH STENT IMPLANTATION INCLUDING THE OSTIUM BEFORE DEFLATION OF THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309036 KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX KANEKA CORPORATION SP109312

    Patients

    Seq Age Sex Outcome Treatment
    1 Other