BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANEKA PTCA CATHETER ZINRAI

    MDR report key: 13962682 · Received March 31, 2022

    Report

    Report Number
    3002808904-2022-00005
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 4, 2022
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "ZINRAI," 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 DISTAL SHAFT WAS ELONGATED AND BROKEN TO SEPARATE AT THE GW PORT (300MM FROM THE DISTAL TIP), AND THE DISTAL PART WAS NOT RETURNED. MIDDLE SHAFT WAS ELONGATED TO 111MM (SPECIFICATION VALUE: 65MM). WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO THE BALLOON/SHAFT BREAK INCLUDE, BUT ARE NOT LIMITED TO, DURING WITHDRAWAL OF THE CATHETER SHAFT , THE DISTAL PART WAS STUCK AT THE CTO LESIONS, AND THEN BROKEN DUE TO EXCESSIVE PULLING FORCE WAS LOADED, WHICH WE ASSUME TO BE DUE TO PROCEDURE AND/OR PATIENT'S VESSEL CONDITION. IN THE INSTRUCTIONS FOR USE OF ZINRAI (3283-0), WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; PRECAUTIONS: IMPORTANT, BASIC PRECAUTIONS: SINCE PTCA PROCEDURE MAY INDUCE DANGEROUS COMPLICATIONS, PERFORM THE PROCEDURE ONLY AFTER HAVING PREPARED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). IF ANY ABNORMALITY SUCH AS STRONG RESISTANCE IS NOTED DURING OPERATION OF THE PRODUCT, STOP THE OPERATION IMMEDIATELY, IDENTIFY THE CAUSE, AND TAKE APPROPRIATE MEASURES. IF FORCED INSERTION OR REMOVAL IS CONTINUED, THE PRODUCT MAY BE DAMAGED AND VASCULAR INJURY MAY OCCUR. CHALLENGING LESIONS SUCH AS CALCIFIED OR TORTUOUS LESIONS MAY NOT BE CROSSED WITH THIS CATHETER. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE WHETHER THIS CATHETER IS APPLICABLE BASED ON HIS/HER PAST EXPERIENCES. THIS CATHETER SHOULD BE USED ONLY BY PHYSICIANS SKILLED IN PERCUTANEOUS VASCULAR THERAPY. DEVICE FAILURES AND ADVERSE EVENTS: THE USE OF THE PRODUCT MAY CAUSE THE FOLLOWING DEVICE FAILURE: SEVERE DEVICE FAILURES, RUPTURE OF CATHETER SHAFT, DIFFICULTY IN REMOVING THE CATHETER.

    Description of Event or Problem · 0

    A CHRONIC TOTAL OCCLUSION LESION IN RCA WAS TREATED BY RETROGRADE APPROACH VIA LAD, AFTER ANTEGRADE APPROACH. AFTER A GUIDEWIRE WAS PASS THROUGH THE LESION, ZINRAI PTCA CATHETER WAS INSERTED AND DELIVERED FOR PRE-DILATION. THE BALLOON WAS DILATED SEVERAL TIMES WITH LOWER PRESSURE. THE ZINRAI PTCA CATHETER WAS STUCK AT THE CTO LESION, AND WHILE WITHDRAWING THE CATHETER, IT WAS BROKEN AND SOME PART OF THE BALLOON WAS LEFT INSIDE PATIENT BODY. STENTS WERE PLACED IN #6 TO #8 IN LAD TO PRESS THE LEFT BALLOON PART TO VESSEL WALL. THE BLOOD FLOW FOR LAD HAD TIMI 3 GRADE IN FINAL, AND PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156908 KANEKA PTCA CATHETER ZINRAI ZINRAI LOX KANEKA CORPORATION SR090108

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other