BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    MDR report key: 8904699 · Received August 19, 2019

    Report

    Report Number
    3002808904-2019-00021
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    July 22, 2019
    Report Date
    August 2, 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

    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. 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 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: WE SPECULATED THAT THE BALLOON WAS DAMAGED AT THE HARD PART OF THE LESION AND RUPTURED BY THE LOAD DURING PRESSURIZATION, AND THE DISSECTION OF THE BLOOD VESSEL OCCURED AT THE TIME.

    Description of Event or Problem · 1

    THE CONCERNED DEVICE WAS USED FOR PRE-DILATATION OF THE MID-LCX, AND THE BALLOON OF THE DEVICE RUPTURED DURING THE THIRD DILATATION (10ATM, 30SECONDS). AT THAT TIME, A SMALL DISSECTION OF THE BLOOD VESSEL OCCURRED AND THE STENT WAS PLACED. THE PATIENT HAS ALREADY BEEN DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700975 KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX KANEKA CORPORATION SP069410

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention