BEUDAMED
    FDA Adverse Event Death Summary report: N

    KANEKA PTCA CATHETER CO-R6 (RAIDEN3)

    MDR report key: 12947324 · Received December 7, 2021

    Report

    Report Number
    3002808904-2021-00012
    Event Type
    Death
    Date Received
    December 7, 2021
    Date of Event
    October 12, 2021
    Report Date
    November 12, 2021
    Manufacturer
    KANEKA CORPORATION
    Product Code
    LOX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "RAIDEN3", 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 WAS DISCARDED AT THE FACILITY, AND WAS NOT RETURNED FOR INVESTIGATION. 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 FOR EVERY PRODUCT, AND THE FINISHED PRODUCT INSPECTIONS ON REPRESENTATIVE SAMPLES BASED ON SAMPLING PLAN. NO NONCONFORMITY OR ABNORMALITY IN THE MANUFACTURING PROCESSES OF THE DEVICE CONCERNED WAS FOUND. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO THE BALLOON RUPTURE AND THE SHAFT BREAK INCLUDE, BUT ARE NOT LIMITED TO, THE BALLOON WAS SCRATCHED WITH A HARD AND SHARP EDGE OF THE STENT AND/OR LESION (LESION CALCIFICATION) OR OTHER DEVICE CONCOMITANTLY USED WHILE THE CATHETER WAS ADVANCED INTO THE LESION. AND THEN, DURING DILATING THE BALLOON FOR POST-DILATATION BALLOON RUPTURE WAS OCCURRED, AND THE BALLOON WAS BROKEN WHILE WITHDRAWING THE CATHETER. FROM THE ADDITIONAL INFORMATION BY INTERVIEW, THE PHYSICIAN WAS TRIED TO RETRIEVE THE PART OF THE BALLOON WITH DIFFERENT DEVICES AND "SNARING" TECHNIQUES. AND, PATIENT DIED DURING THE OPERATION DUE TO AN INTRASTENT THROMBOTIC EVENT IN THE COMMON SEGMENT DURING THE TENTATIVE TO REMOVE THE PART OF THE BALLOON. IN THE INSTRUCTIONS FOR USE OF RAIDEN3 (3215-4) , 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. IF ABNORMAL OR STRONG RESISTANCE IS EXPERIENCED DURING THE OPERATION, THE CAUSE FOR SUCH ABNORMALITY OR RESISTANCE SHOULD BE VERIFIED AND APPROPRIATE MEASURES SHOULD BE PERFORMED BEFORE PROCEEDING. (IF SUCH ABNORMALITY OR RESISTANCE IS IGNORED AND EXCESSIVE FORCE IS APPLIED, IT MAY LEAD TO DAMAGE OF THE VESSELS OR TO THE CATHETER SHAFT BREAKING AND REMAINING INSIDE THE BODY). 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

    OUR DISTRIBUTOR IN (B)(4) RECEIVED, ON 11 NOV 2021, A CERTIFIED EMAIL FROM (B)(6) COMPETENT AUTHORITY, WHICH INFORMS US ABOUT THE DEATH OF A PATIENT. ON (B)(6) 2021 THE PATIENT WENT UNDERGO A COMPLEX PERCUTANEOUS ANGIOPLASTY ON "TC/IVA AND CX". DURING THE OPERATION, AFTER SEVERAL STENTS ON "CX/IVA AND TC", DURING FINAL POST-DILATION ON THE AXIS "TC/IVA CX" WITH NON-COMPLIANT BALLOONS, SURGEON IDENTIFIED A PERFORATION ONE OF THOSE TWO BALLOONS AFTER THE DILATATION, AND RELATIVE DETACH OF A DISTAL PART OF THE BALLOON WHICH MOVED IN THE PERIPHERY OF THE CORONARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1851412 KANEKA PTCA CATHETER CO-R6 (RAIDEN3) RAIDEN3 LOX KANEKA CORPORATION SR051639

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Unknown Death