NEON NC PTCA BALLOON DILATATION CATHETER
Report
- Report Number
- 3002808904-2025-00008
- Event Type
- Injury
- Date Received
- March 16, 2025
- Date of Event
- February 19, 2025
- Report Date
- February 21, 2025
- Manufacturer
- KANEKA CORPORATION
- Product Code
- LOX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "NEON NC", 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 WERE 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. RESULTS OF THE INVESTIGATION ON RETURNED CONCERNED DEVICE: THE INNER TUBE (GW LUMEN) WAS ELONGATED AND TORN TO SEPARATE AT 243MM FROM THE DISTAL TIP. WHEN THE INFLATION LUMEN WAS PRESSURIZED BY WATER, LEAKAGE WAS OBSERVED FROM THE GW PORT DUE TO THE GW LUMEN AND THE INFLATION LUMEN WAS CONNECTED. WE ASSUME THE CAUSE OF THIS AS FOLLOWS: FACTORS THAT MAY CONTRIBUTE TO INFLATION FAILURE AND LEAKAGE INCLUDE, BUT ARE NOT LIMITED TO, WHILE THE BALLOON PROTECTION MATERIALS (THE STYLET AND THE BALLOON PROTECTION TUBE) WERE REMOVED, THE INNER SHAFT WAS ELONGATED AND SEPARATED AT THE THIN PART OF INNER SHAFT AND LOCAL RESISTANCE OCCURRED, WHICH WAS DUE TO HANDLING DURING PREPARATION AND DURING INSERTING THE CATHETER ALONG WITH CONCOMITANTLY USED GW. THE PATIENT CONDITION OF GAS EMBOLISM AND CARDIORESPIRATORY ARREST MIGHT HAVE OCCURRED DUE TO THE PROCEDURE AND/OR PATIENT CONDITION. IN THE INSTRUCTIONS FOR USE OF NEON NC (3230-3) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS RELATED TO PROCEDURES] 2. USE THE INFLATION FLUID TO INFLATE THE BALLOON. NO GASEOUS BODY SUCH AS AIR SHOULD BE USED FOR INFLATION. [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.
THE CONCERNED DEVICE SUBJECT TO THIS REPORTED EVENT, "NEON NC", 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 WERE 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 WILL PROCEED THE INVESTIGATION OF CONCERNED PRODUCT ONCE IT IS RETURNED FROM THE DISTRIBUTOR. IN THE INSTRUCTIONS FOR USE OF NEON NC (3230-3) , WE STATE THE POTENTIAL OF KNOWN RISK AS BELOW; [PRECAUTIONS RELATED TO PROCEDURES] 2. USE THE INFLATION FLUID TO INFLATE THE BALLOON. NO GASEOUS BODY SUCH AS AIR SHOULD BE USED FOR INFLATION. [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.
THE LESION HAD SIGNIFICANT LONG STENOSIS OF THE PROXIMAL LEFT CORONARY ARTERY, ENCOMPASSING THE ORIGIN OF THE FIRST DIAGONAL (BIFURCATION LESION) AND TIGHT STENOSIS OF THE DISTAL ANTERIOR LEFT CORONARY ARTERY. THE FIRST DIAGONAL WAS SIGNIFICANT CHRONIC SHORT STENOSIS. ANGIOPLASTY OF THE PROXIMAL AND DISTAL ANTERIOR LEFT CORONARY ARTERY WERE SUCCESSFUL, BUT THE ANGIOPLASTY FOR THE FIRST DIAGONAL WAS FAILED. THEN, DURING POST-STENT DILATATION USING CONCERNED NEON NC PTCA BALLOON WITH A MAXIMUM PRESSURE OF 12 ATM FOR A TOTAL DURATION OF 20 SEC, LEAKAGE FROM THE BALLOON WAS OCCURRED, WHICH CONSEQUENCE AIR EMBOLIZATION IN LEFT CORONARY ARTERY, LOSS OF FLOW IN LEFT CORONARY ARTERY LEADING TO CARDIORESPIRATORY ARREST, MCE ABOUT 5 MINUTES AND ADRENALINE 1MG, HIGH-FLOW OXYGENATION. RECOVERY OF SPONTANEOUS CARDIAC ACTIVITY BUT SIGNIFICANT DROWSINESS WARRANTING TRANSFER TO INTENSIVE CARE FOR NEUROLOGICAL MANAGEMENT. THE PATIENT WAS RECOVERED FROM THE CARDIOPULMONARY ARREST, BUT PERSISTENCE OF NEUROLOGICAL DISORDERS (CENTRAL FACIAL PARALYSIS WITH DIPLOPIA, NO SENSORY-MOTOR DEFICIT IN UPPER AND LOWER LIMBS).
THE LESION HAD SIGNIFICANT LONG STENOSIS OF THE PROXIMAL LEFT CORONARY ARTERY, ENCOMPASSING THE ORIGIN OF THE FIRST DIAGONAL (BIFURCATION LESION) AND TIGHT STENOSIS OF THE DISTAL ANTERIOR LEFT CORONARY ARTERY. THE FIRST DIAGONAL WAS SIGNIFICANT CHRONIC SHORT STENOSIS. ANGIOPLASTY OF THE PROXIMAL AND DISTAL ANTERIOR LEFT COROCARY ARTERY WERE SUCCESSFUL, BUT THE ANGIOPLASTY FOR THE FIRST DIAGONAL WAS FAILED. THEN, DURING POST-STENT DILATATION USING CONCERNED NEON NC PTCA BALLOON WITH A MAXIMUM PRESSURE OF 12 ATM FOR A TOTAL DURATION OF 20 SEC, LEAKAGE FROM THE BALLOON WAS OCCURRED, WHICH CONSEQUENCE AIR EMBOLIZATION IN LEFT CORONARY ARTERY, LOSS OF FLOW IN LEFT CORONARY ARTERY LEADING TO CARDIORESPIRATORY ARREST, MCE ABOUT 5 MINUTES AND ADRENALINE 1MG, HIGH-FLOW OXYGENATION. RECOVERY OF SPONTANEOUS CARDIAC ACTIVITY BUT SIGNIFICANT DROWSINESS WARRANTING TRANSFER TO INTENSIVE CARE FOR NEUROLOGICAL MANAGEMENT. THE PATIENT WAS RECOVERED FROM THE CARDIOPULMONARY ARREST, BUT PERSISTENCE OF NEUROLOGICAL DISORDERS (CENTRAL FACIAL PARALYSIS WITH DIPLOPIA, NO SENSORY-MOTOR DEFCIT IN UPPER AND LOWER LIMBS).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 14197 | NEON NC PTCA BALLOON DILATATION CATHETER | NEON NC | LOX | KANEKA CORPORATION | SR124086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Hospitalization |