KANEKA PTCA CATHETER CO-R6 (RAIDEN3)
Report
- Report Number
- 3002808904-2025-00019
- Event Type
- Injury
- Date Received
- June 6, 2025
- Date of Event
- April 17, 2025
- Report Date
- May 14, 2025
- Manufacturer
- KANEKA CORPORATION
- Product Code
- LOX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 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 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. WE WILL PROCEED THE INVESTIGATION OF CONCERNED PRODUCT ONCE IT IS RETURNED FROM THE DISTRIBUTOR. IN THE INSTRUCTIONS FOR USE OF RAIDEN3 (3215-4) , 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. 9. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. 19 . CHALLENGING LESIONS SUCH AS CALCIFIED OR TORTUOUS LESIONS MAY NOT BE CROSSED WITH THIS CATHETER. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETER MINE WHETHER THIS CATHETER IS APPLICABLE BASED ON HIS/HER PAST EXPERIENCES. 23. IF ANY ABNORMALITIES ARE DETECTED DURING INFLATION OF THE BALLOON, APPLY NEGATIVE PRESSURE IMMEDIATELY AND INTERRUPT THE OPERATION. [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.
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 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 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 BALLOON HAD A HOLE AT 12 TO 13MM FROM THE DISTAL TIP. SCRATCH MARKS WERE OBSERVED NEAR THE HOLE. THE DISTAL SHAFT HAD SCRATCHED AND DEFORMED TO COLLAPSED. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO INFLATION FAILURE AND BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, THE SITUATION OF THE PATIENT'S VASCULATURE LESIONS SUCH AS CALCIFICATION ETC., OVER-INFLATION, FRICTION AT STENT EDGE. SINCE THERE ARE NO ABNORMALITIES IN THE MANUFACTURING RECORDS, WE ASSUME THAT THE BALLOON RUPTURE AND THE CONSEQUENCE OF OCCLUSION AT LEFT-MAIN ARTERY MIGHT BE OCCURRED DUE TO THE PROCEDURE AND/OR PATIENT CONDITION. IN THE INSTRUCTIONS FOR USE OF RAIDEN3 (3215-4) , 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. 9. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. 19 . CHALLENGING LESIONS SUCH AS CALCIFIED OR TORTUOUS LESIONS MAY NOT BE CROSSED WITH THIS CATHETER. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETER MINE WHETHER THIS CATHETER IS APPLICABLE BASED ON HIS/HER PAST EXPERIENCES. 23. IF ANY ABNORMALITIES ARE DETECTED DURING INFLATION OF THE BALLOON, APPLY NEGATIVE PRESSURE IMMEDIATELY AND INTERRUPT THE OPERATION. [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.
THE RAIDEN3 CATHETER WITH 4.25X15MM BALLOON WAS USED TO POST-DILATED STENT AT THE DISTAL PART OF LEFT-MAIN ARTERY. IT WAS THE FINAL STEP TO FINISH THE CASE. WHEN THE PRESSURE REACHED 4 ATM, WHICH IS NOT THE RATED BURST PRESSURE, THE BALLOON BURST AND THE CONTRAST SOLUTION BURST OUT. THE INCIDENT CAUSED THE OCCLUSION AT LEFTMAIN IMMEDIATELY, FORTUNATELY, THE MEDICAL TEAM CAN SAVE THE PATIENT. DOCTOR PLACED A BACKUP WIRE IN THE LCX BRANCH, BESIDE THE WIRE IN THE LAD BRANCH. THE DOCTOR TEAM TRY TO OPEN THE LUMEN AGAIN, IT WORKED, SO THE PATIENT WAS SAVED. THE PATIENT RECOVERED WELL AND TO BE DISCHARGED FROM HOSPITAL.
THE RAIDEN3 CATHETER WITH 4.25X15MM BALLOON WAS USED TO POST-DILATED STENT AT THE DISTAL PART OF LEFT-MAIN ARTERY. IT WAS THE FINAL STEP TO FINISH THE CASE. WHEN THE PRESSURE REACHED 4 ATM, WHICH IS NOT THE RATED BURST PRESSURE, THE BALLOON BURSTED AND THE CONTRAST SOLUTION BURSTED OUT. THE INCIDENT CAUSED THE OCCLUSION AT LEFT-MAIN IMMEDIATELY, FORTUNATELY, THE MEDICAL TEAM CAN SAVE THE PATIENT. DOCTOR PLACED A BACKUP WIRE IN THE LCX BRANCH, BESIDE THE WIRE IN THE LAD BRANCH. THE DOCTOR TEAM TRY TO OPEN THE LUMEN AGAIN, IT WORKED, SO THE PATIENT WAS SAVED. THE PATIENT RECOVERED WELL AND TO BE DISCHARGED FROM HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1493330 | KANEKA PTCA CATHETER CO-R6 (RAIDEN3) | RAIDEN3 | LOX | KANEKA CORPORATION | SR074374 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female | Required Intervention |