KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
Report
- Report Number
- 3002808904-2022-00006
- Event Type
- Malfunction
- Date Received
- April 14, 2022
- Date of Event
- March 21, 2022
- Report Date
- March 21, 2022
- Manufacturer
- KANEKA CORPORATION
- Product Code
- LOX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
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. WE WILL PROCEED THE INVESTIGATION OF CONCERNED PRODUCT ONCE IT IS RETURNED FROM THE DISTRIBUTOR. 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. 9. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. 14. 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.
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 INNER TUBE (GW LUMEN) WAS BROKEN AT THE DISTAL RADIOPAQUE MARKER, AND A RING MARKER WAS MISSING. THE BALLOON WAS TORN AT 6MM FROM THE PROXIMAL RADIOPAQUE MARKER. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO THE DISTAL TIP AND THE BALLOON BREAK INCLUDE, BUT ARE NOT LIMITED TO, AFTER THE BALLOON WAS RUPTURED DUE TO CALCIFIED LESION, WHILE WITHDRAWAL OF THE CATHETER SHAFT, THE DISTAL PART WAS STUCK AT THE HEAVILY CALCIFIED LESIONS, AND THEN BROKEN DUE TO EXCESSIVE PULLING FORCE WAS LOADED, WHICH WE ASSUME TO BE DUE TO PROCEDURE AND/OR PATIENT'S VESSEL CONDITION. 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. 9. THE PHYSICIAN IN CHARGE OF THE PROCEDURE SHOULD DETERMINE THE DURATION AND NUMBER OF BALLOON INFLATIONS BASED ON HIS/HER PAST EXPERIENCES. 14. 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.
ON 21 MARCH THE CUSTOMER SENT THE FORM THAT CONTAINS THE INCIDENT REPORT. DURING THE PREDILATATION OF CALCIFIED LESION WITH A 3.5X30MM AT 8 ATM BALLOON THE BALLOON BROKE. DURING THE ANGIOGRAPHY THE VESSEL APPEARED OCCLUDED AND THE TIP AND PART OF THE BALLOON WERE MISSING. ANOTHER GUIDE WAS PLACED AND SURGEON TWISTED THE GUIDE WITH TORTUOSITY. THEN SURGEON REMOVED THE GUIDING CATHETER AND GUIDES TOGETHER. THEN A NEW CATHETER WAS PLACED AND THE STENT WAS RELEASED WITH GOOD RESULT.
ON 21 MARCH THE CUSTOMER SEND THE FORM THAT CONTAINS THE INCIDENT REPORT. DURING THE PREDILATATION OF CALCIFIED LESION WITH A 3.5X30MM AT 8 ATM BALLOON THE BALLOON BROKE. DURING THE ANGIOGRAPHY THE VESSEL APPEARED OCCLUDED AND THE TIP AND PART OF THE BALLOON WERE MISSING. ANOTHER GUIDE WAS PLACED AND SURGEON TWISTED THE GUIDE WITH TORTUOSITY. THEN SURGEON REMOVED THE GUIDING CATHETER AND GUIDES TOGETHER. THEN A NEW CATHETER WAS PLACED AND THE STENT WAS RELEASED WITH GOOD RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2172802 | KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO) | IKAZUCHI ZERO | LOX | KANEKA CORPORATION | SR081059 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Unknown | Other |