BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANEKA PTCA CATHETER CO-R8 (TASUKI)

    MDR report key: 10999736 · Received December 13, 2020

    Report

    Report Number
    3002808904-2020-00022
    Event Type
    Injury
    Date Received
    December 13, 2020
    Date of Event
    November 26, 2020
    Report Date
    November 26, 2020
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "TASUKI", 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: DURING USE, A BALLOON WAS DILATED 14 TIMES WITH PRESSURE INCLUDING EXCEEDED RATED BURST PRESSURE, AND RUPTURED. A PART OF THE BALLOON AND THE CATHETER (DISTAL TIP) REACHED THE BREAK BY BEING LOAD OF THE EXCESSIVE PULLING FORCE IN THE SEVERE CALCIFIED LESION. THE LENGTH OF THE RESIDUAL PART INSIDE THE PATIENT BODY WAS ASSUMED APPROXIMATELY 16MM INCLUDING DISTAL TIP, A RADIOPAQUE MARKER, AND BALLOON. WE CONCLUDED THAT THE INCIDENT IS DETERMINED NOT TO BE CAUSED BY ANY DEFECT OF THE DEVICE, BUT TO BE CAUSED BY PROCEDURE/USER.

    Description of Event or Problem · 1

    TASUKI WAS INSERTED INTO THE SEVERE CALCIFIED LESION AND WAS DILATED 14 TIMES WITH PRESSURE INCLUDING EXCEEDED RATED BURST PRESSURE. WHILE WITHDRAWING THE CATHETER, THE PHYSICIAN FELT SOME DIFFICULTY AND RESISTANCE DUE TO THE SEVERE CALCIFICATION. THE DISTAL TIP AND A PART OF BALLOON COULD NOT BE REMOVED FROM THE LCX LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463206 KANEKA PTCA CATHETER CO-R8 (TASUKI) TASUKI LOX KANEKA CORPORATION SP128011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other