BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    MDR report key: 20288472 · Received September 24, 2024

    Report

    Report Number
    3002808904-2024-00008
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 -BATCH RECORD) COULD NOT BE INVESTIGATED BECAUSE THE LOT NUMBER IS UNKNOWN. EVERY PRODUCTION LOT PASSED ALL IN-PROCESS INSPECTIONS AND FINISHED PRODUCT INSPECTIONS BEFORE SHIPMENT. WE ASSUME THAT A PART OF THE BALLOON AND THE CATHETER REACHED THE BREAKAGE BY BEING LOAD OF THE EXCESSIVE ADVANCE/PULLING FORCE IN THE SEVERE LESION. IN THE INSTRUCTIONS FOR USE OF IKAZUCHI ZERO (3216-4) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS DURING USAGE], [IMPORTANT BASIC PRECAUTIONS], 1. THIS CATHETER MAY BE USED ONLY BY PHYSICIANS SKILLED IN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. 7. SINCE PTCA PROCEDURE MAY INDUCE DANGEROUS COMPLICATIONS, PERFORM THE PROCEDURE ONLY AFTER HAVING PREPARED FOR EMERGENCY CORONARY ARTERY BYPASS GRAFTING (CABG). 8. SINCE SERIOUS COMPLICATIONS MIGHT ARISE WHEN USING THIS CATHETER, OPERATION SHOULD BE DONE IN THE MEDICAL INSTITUTION WHERE EMERGENCY PROCEDURE CAN BE EXECUTED. [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 · 0

    WE, MANUFACTURER KANEKA, FOUND THIS REPORT AS STUDY LITERATURE SURVEY, TITLE: FRACTURED AND ENTRAPPED CORONARY ANGIOPLASTY BALLOON SUCCESSFULLY MANAGED WITH ROTATIONAL ATHERECTOMY, JOURNAL: CJC OPEN, 2024. FIRST, SEMI-COMPLIANT (SC) BALLOON DILATION WAS PERFORMED ON THE MID RCA LESION. THEN, UNDER THE SUPPORT OF A 6F GUIDEZILLA II (BOSTON SCIENTIFIC, MARLBOROUGH, MA), GUIDE SUPPORT EXTENSION CATHETER, THE PLA LESION WAS UNEVENTFULLY TREATED WITH ONE 3.0 X 40MM DRUG-ELUTING STENT (DES). AFTERWARDS, WE PROCEEDED TO MID-RCA LESION PREPARATION WITH MULTIPLE PRE-DILATATION CYCLES WITH SC BALLOONS OF INCREASING CALIBER. WHILE RETRACTING A 4.0 X 15MM IKAZUCHI (KANEKA, CORDIS, HIALEAH, FL) SC BALLOON INTO THE GUIDEZILLA II, RESISTANCE WAS FOUND, IMMEDIATELY FOLLOWED BY DOCUMENTATION OF SHAFT FRACTURE, WITH DISTAL SEPARATION FROM THE PROXIMAL END OF THE BALLOON, WITH EMBOLIZATION AND ENTRAPMENT IN THE MID-RCA LESION. DESPITE THIS COMPLICATION, A TIMI 2 FLOW WAS STILL MAINTAINED. AT THE TIME, WE CONSIDERED MULTIPLE TECHNIQUES TO RETRIEVE THE EMBOLIZED MATERIAL. AT THIS POINT, DURING THE ATTEMPTS TO RETRIEVE THE ENTRAPPED BALLOON, AN IATROGENIC RCA OSTIAL DISSECTION OCCURRED AND WAS TREATED WITH DIRECT STENTING USING 5.0 X 24 MM DES. WE ADVANCED A CORSAIR PRO MICROCATHETER (ASHAI INTECC CO., JAPAN) WITH EXTREME DIFFICULTY, ALLOWING GUIDEWIRE EXCHANGE FOR ROTAWIRE FLOPPY (BOSTON SCIENTIFIC, MARLBOROUGH, MA); THEN PROCEEDED WITH ROTABLATION USING A 1.25MM BURR (BOSTON SCIENTIFIC, MARLBOROUGH, MA), WITH SUCCESSFUL ROTABLATION AFTER MULTIPLE RUNS AT 180.000 RPM. THEN, WE WERE ABLE TO ADVANCE MATERIAL AND CRACKED THE "BALLOON-LESION COMPLEX" WITH 4.0MM NON-COMPLIANT (NC) EMERGE BALLOON (BOSTON SCIENTIFIC, MARLBOROUGH, MA), PROCEEDING WITH THREE CONSECUTIVE STENTS (4.0 X 40MM, 4.5 X 32MM AND 5.0 X 15MM DES), FROM THE PREVIOUSLY IMPLANTED PLA STENT TO THE PREVIOUSLY IMPLANTED OSTIAL RCA STENT . IN THE END, THERE WAS GOOD FINAL ANGIOGRAPHIC RESULT WITH NO EVIDENCE OF DISTAL EMBOLIZATION DURING OR POST ROTABLATION. BOTH IN-HOSPITAL AND 12-MONTH FOLLOW-UP WERE UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1878737 KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) IKAZUCHI ZERO LOX KANEKA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other