BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANEKA PTCA CATHETER CO-R8 (TASUKI)

    MDR report key: 21194588 · Received January 21, 2025

    Report

    Report Number
    3002808904-2025-00001
    Event Type
    Injury
    Date Received
    January 21, 2025
    Date of Event
    December 4, 2024
    Report Date
    January 6, 2025
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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: THE CATHETER SHAFT WAS TORN AND BROKEN TO SEPARATE AT GW PORT. THE MIDDLE SHAFT WAS ELONGATED. THE DISTAL PART OF THE SHAFT WAS NOT RETURNED FOR EVALUATION. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO BREAKAGE OF THE CATHETER SHAFT INCLUDE, BUT ARE NOT LIMITED TO, THE CATHETER SHAFT WAS INSERTED INTO SEVERE VESSEL CONDITION OR COOMPLEX LESION AT THE STENTING SITE, WHICH CASED THE CATHETER SHAFT BECAME TRAPPED, AND THEN WHILE REMOVAL, THE EXCESSIVE PULLING FORCE WAS LOADED WHICH CAUSE THE HEALTH CONSEQUENSE AND ADDITIONAL SURGERY. IN THE INSTRUCTIONS FOR USE OF TASUKI (2394-0) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS] <IMPORTANT, BASIC PRECAUTIONS> 1. SINCE PTCA PROCEDURE MAY INDUCE DANGEROUS COMPLICATIONS, PERFORM THE PROCEDURE ONLY AFTER HAVING PREPARED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). 6. 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.] 7. 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. [DEVICE FAILURES AND ADVERSE EVENTS] THE USE OF THE PRODUCT MAY CAUSE THE FOLLOWING DEVICE FAILURE: 1. SEVERE DEVICE FAILURES (3) RUPTURE OF CATHETER SHAFT (4) DIFFICULTY IN REMOVING THE CATHETER.

    Description of Event or Problem · 0

    AT A PCI OPERATION, THE CONCERNED TASUKI PTCA BALLOON WAS USED FOR POST DILATATION OF A SYNERGY MEGATRON STENT (BOSTON SCIENTIFIC) IMPLANTED IN LMT TO LAD. A RYUREI BALLOON (TERUMO) AND THE BALLOON OF SYNERGY MEGATRON STENT WERE TRIED TO DILATED TOGETHER BY KISSING BALLOON TECHNIQUE, BUT THE BALLOON COULD NOT BE REACHED TO THE LESION. WHILE THE BALLOON WAS WITHDRAWAL, THE GW WAS MOVED AND NEEDED TO BE INSERTED TO THE LESION AGAIN. THE CONERNED TASUKI PTCA BALLOON WAS INSERTED AND DILATED. AFTER THEN, WHILE WITHDRAWAL, THE DISTAL PART OF THE TASUKI WAS BROKEN TO SEPARATE AND PARTIALLY REMAINED IN THE CORONARY ARTERY. THE BROKEN PART COULD NOT BE REMOVED BY THE PCI BAILOUT. THE PATIENT WAS SENT TO A SURGICAL SURGERY TO REMOVE THE BROKEN PART NEXT DAY TO FULLY REMOVED. A COMMNET FROM A CLINICAL ENGINEER : WHILE THE GW WAS RE-INSERTED, IT MIGHT WENT INTO STENT STRUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662696 KANEKA PTCA CATHETER CO-R8 (TASUKI) TASUKI LOX KANEKA CORPORATION SR083539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other