BEUDAMED
    FDA Adverse Event Death Summary report: N

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    MDR report key: 11662857 · Received April 14, 2021

    Report

    Report Number
    3002808904-2021-00004
    Event Type
    Death
    Date Received
    April 14, 2021
    Date of Event
    March 2, 2021
    Report Date
    March 19, 2021
    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. WE CONDUCTED DHR REVIEW; AS FOR BALLOONS, WE USE ONLY BALLOONS THAT HAVE WITHSTOOD RBP 20 TIMES OR MORE IN SAMPLING INSPECTIONS FOR EACH RAW MATERIAL LOT AND HAVE BEEN CONFIRMED TO BURST AT RBP OR HIGHER AND TO BREAK VERTICALLY (= DO NOT BREAK LATERALLY) EVEN IF THEY ARE INTENTIONALLY BURST. ALSO, IN THE FINAL PRODUCT SAMPLING INSPECTION, WE DO A PRESSURE RESISTANCE TEST FOR EACH LOT TO CONFIRM THAT IT DOES NOT BURST WITHIN RBP. FROM THE RESULT OF DHR REVIEW OF CONCERNED IKAZUCHI ZERO ZE-15-250 WITH LOT SR090610, IT PASSED ALL THE TESTS AND NO NONCONFORMITY OR ABNORMALITY WAS FOUND IN MANUFACTURING PROCESS. RESULTS OF THE INVESTIGATION ON RETURNED CONCERNED DEVICE: THE DISTAL SHAFT WAS SLIGHTLY ELONGATED AND BROKEN AT THE GW PORT. THE DISTAL PART OF THE CATHETER SHAFT WAS NOT RETURNED. WE CONDUCTED BALLOON PRESSURE RESISTANCE TEST ON A SAMPLE FROM THE SAME PRODUCTION LOT OF IKAZUCHI ZERO ZE-15-250, SR090610. THE SAMPLE PASSED THE TEST, THE CATHETER SHAFT AND/OR THE BALLOON DID NOT HAVE LEAKAGE AND BURST/RUPTURE WHILE PRESSURIZED WITH RBP VALUE FOR 10 TIMES. ACCORDING TO THE RESULTS, THE INCIDENT IS ASSUMED NOT TO BE CAUSED BY ANY DEFECT OF THE DEVICE. FACTORS THAT MAY CONTRIBUTE TO THE BALLOON RUPTURE AND THE SHAFT BREAK INCLUDE, BUT ARE NOT LIMITED TO, DURING DILATING THE BALLOON FOR THE PURPOSE OF HEMOSTAT THE BLOOD VESSEL RUPTURED, SUDDEN BALLOON RUPTURE OCCURRED WHICH WE ASSUME TO BE DUE TO PROCEDURE AND/OR PATIENT'S VESSEL CONDITION. FROM THE ADDITIONAL INFORMATION, CORONARY RUPTURE WAS OCCURRED DURING USING A ROTABLATOR, AND THEN THE CONCERNED IKAZUCHI ZERO WAS USED FOR HEMOSTASIS. THE PHYSICIAN IN CHARGE ADMITTED THAT RUPTURE OF THE BALLOON WAS NOT THE CAUSE OF DEATH BUT INCREASE COMPLICATION OF AN ALREADY COMPLICATED PROCEDURE WHERE THE BALLOON WAS USED FOR HEMOSTASIS. IN THE INSTRUCTIONS FOR USE OF IKAZUCHI ZERO (3216-3) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS DURING USAGE]: [IMPORTANT BASIC PRECAUTIONS]; THIS CATHETER MAY BE USED ONLY BY PHYSICIANS SKILLED IN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. SINCE PTCA PROCEDURE MAY INDUCE DANGEROUS COMPLICATIONS, PERFORM THE PROCEDURE ONLY AFTER HAVING PREPARED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). SINCE SERIOUS COMPLICATIONS MIGHT ARISE WHEN USING THIS CATHETER, OPERATION SHOULD BE DONE IN THE MEDICAL INSTITUTION WHERE EMERGENCY PROCEDURE CAN BE EXECUTED. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. [ADVERSE EVENTS]: ADVERSE EVENTS RELATED TO THE PRODUCT INCLUDE, BUT ARE NOT LIMITED TO, INFARCTION CAUSED BY OCCLUSION OF DISTAL VESSELS OR SIDE BRANCH, VASOSPASM, STRIPPING OF VASCULAR ENDOTHELIUM, DISSECTION OF VASCULAR INTIMA, RE-OCCLUSION, VASCULAR PERFORATION OR RUPTURE, UNSTABLE ANGINA, BLOOD PRESSURE FLUCTUATION, STROKE, SHOCK, REACTION TO DRUGS, REACTION TO CONTRAST MEDIA, RENAL INSUFFICIENCY, TRANSIENT ISCHEMIA, AIR EMBOLISM, THROMBOEMBOLISM, INTERNAL BLEEDING, HEMATOMA, INFECTION, ETC. THESE ADVERSE EVENTS MAY CAUSE EMERGENT CORONARY BYPASS SURGERY, MYOCARDIAL INFARCTION, RE-STENOSIS, CARDIAC TAMPONADE, HEMORRHAGE, EMERGENT BRAIN SURGERY FOR CEREBRAL INFARCTION, FORMATION OF VESSEL FISTULA, ANEURYSM, ARRHYTHMIA, AND EVEN DEATH.

    Description of Event or Problem · 1

    CALCIFIED STENOSIS IN MID LAD WAS TREATED BY ROTABLATOR. DURING THE ROTABLATOR PROCEDURE, SUDDEN CORONARY RUPTURE WAS OCCURRED. THE CONCERNED IKAZUCHI ZERO BALLOON WAS USED FOR HEMOSTASIS. IT WAS INSUFFICIENT, AFTER INFLATION, IT GOT STUCK IN THE LESION DURING THE WITHDRAWAL TO PUT ANOTHER BALLOON FOR HEMOSTASIS, THE WITHDRAWAL REQUIRED STRONG TRACTION LEADING TO THE RUPTURE OF THE SHAFT THAT LED TO THE WITHDRAWAL OF ALL THE MATERIAL TO RECOVER THE BALLOON. IN AGREEMENT WITH THE PHYSICIAN IN CHARGE OF RESCUCITATION, AFTER A VERY LONG AND COMPLICATED PROCEDURE AFTER A LONG RESUSCITATION IT WAS THEN DECIDED TO STOP THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561951 KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) IKAZUCHI ZERO LOX KANEKA CORPORATION SR090610

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death