BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    MDR report key: 19858827 · Received July 30, 2024

    Report

    Report Number
    3002808904-2024-00006
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 17, 2024
    Report Date
    July 18, 2024
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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) 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 HAD A TRACE OF TWISTED AT 23MM AND AT 31MM FROM THE DISTAL TIP. THE OUTER SHAFT (INFLATION LUMEN) WAS ELONGATED AND SHRUNK INTO BELLOWS SHAPE AT THE PROXIMAL SIDE OF BALLOON, 27 TO 36MM FROM THE DISTAL TIP. ALSO, THE DISTAL SHAFT WAS COLLAPSED TO NARROW. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO DEFLATION FAILURE INCLUDE, BUT ARE NOT LIMITED TO, THE CATHETER SHAFT CLOSE TO THE BALLOON-PROXIMAL PART WAS TWISTED AND DEFORMED TO COLLAPSE WHEN THE CATHETER WAS INSERTED INTO SEVERE CALCIFIED LESION, WHICH CAUSED COLLAPSE OF THE INFLATION LUMEN. THE OUTER SHAFT WAS ELONGATED AND SHRUNK INTO BELLOWS SHAPE AT THE PROXIMAL SIDE OF BALLOON THAT MIGHT BE CAUSED BY PULLING BACK THE BALLOON CATHETER WHILE THE BALLOON WAS NOT SUFFICIENTLY DEFLATED, AND WHICH CAUSE THE HEALTH CONSEQUENSE OF DISSECTION AND HEMATOMA. IN THE INSTRUCTIONS FOR USE OF IKAZUCHI ZERO (3216-4) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS RELATED TO PROCEDURES] 4. DO NOT MOVE THIS CATHETER WHILE THE BALLOON IS INFLATED IN THE BLOOD VESSEL. (MOVING THE CATHETER WITH THE BALLOON INFLATED MAY LEAD TO BLOOD VESSEL INJURY, BALLOON BURST, AND CATHETER BREAKAGE.) [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. 9. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. 13 . DO NOT TWIST OR TURN THIS BALLOON CATHETER OR THE GUIDEWIRE DURING OPERATION. (THE CATHETER MAY BE TANGLED INCREASING THE RESISTANCE.) 18 . DUE TO THE LACK OF CONDUCTIVITY OF TWIST FORCES, THE CATHETER SHAFT SHOULD NO T BE TWISTED IF TWISTED, THE CATHETER SHAFT MAY BE DAMAGED AND THEN REMAIN INSIDE THE BODY). 19 . CHALLENGING LESIONS SUCH AS CALCIFIED OR TORTUOUS LESIONS MAY NOT BE CROSSED WITH THIS CATHETER. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE WH E THER THIS CATHETER IS APPLICABLE 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 · 0

    IT WAS A CORONIC TOTAL OCLUSION CASE. DURING MDRCA LESION TREATMENT, BALLOON CATHETER WAS NOT ABLE TO DEFLATE. DISSECTION AND HEMATOMA OCCURRED IN THE PROCESS OF REMOVING BALLOON CATHETER AS THE PATIENT BECAME VITAL SIGN ABNORMAL. THE PROCEDURE WAS CONTINUED, AND THE PATIENT'S TREATMENT ENDED WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281906 KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) IKAZUCHI ZERO LOX KANEKA CORPORATION SR024481

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other