BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    MDR report key: 11044196 · Received December 21, 2020

    Report

    Report Number
    3002808904-2020-00023
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 23, 2020
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    505

    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. 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: THE MIDDLE SHAFT WAS ELONGATED AND TORN AT THE DISTAL END OF THE PROXIMAL SHAFT (HYPOTUBE). THE DISTAL SHAFT TO MIDDLE SHAFT WAS NOT RETURNED AND COULD NOT BE INVESTIGATED. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: DURING USE, THE DISTAL TIP, THE BALLOON, AND/OR THE GW LUMEN WAS CAUGHT BY THE LESION OR THE COMBINATION DEVICE ETC., AND WHEN PULLED FORCIBLY THE CATHETER WAS ELONGATED AND FINALLY BROKEN. WE CONCLUDED THAT THE INCIDENT IS DETERMINED NOT TO BE CAUSED BY ANY DEFECT OF THE DEVICE.

    Description of Event or Problem · 1

    IKAZUCHI ZERO WAS INSERTED INTO THE LESION IN RIGHT CORONARY ARTERY AND WAS DILATED. WHILE WITHDRAWING THE CATHETER AFTER DILATION, THE PART OF THE CATHETER WAS STUCK AT THE LESION AND COULD NOT REMOVE TOTALLY. THE PART OF THE BALLOON WAS LEFT IN THE ARTERY. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516710 KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) IKAZUCHI ZERO LOX KANEKA CORPORATION SR040407

    Patients

    Seq Age Sex Outcome Treatment
    1 Other