MAUDE Adverse Event Report: KANEKA CORPORATION KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

Catalog Number ZE-20-300

Device Problem Material Rupture (1546)

Patient Problems Cardiac Arrest (1762); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 01/21/2021

Event Type  Death  

Manufacturer Narrative

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.We conducted dhr review; as for balloons, we use only balloons that have withstood rbp 20 times or more in sampling inspections for each raw material lot and have been confirmed to burst at rbp or higher and to break vertically (= do not break laterally) even if they are intentionally burst.Also, in the final product sampling inspection, we do a pressure resistance test for each lot to confirm that it does not burst within rbp.From the result of dhr review of concerned ikazuchi zero ze-20-300 with lot sr060456, it passed all the tests and no nonconformity or abnormality was found in manufacturing process.We conducted balloon pressure resistance test on a sample from the same production lot of ikazuchi zero ze-20-300, sr060456.The sample passed the test, the catheter shaft and/or the balloon did not have leakage and burst/rupture while pressurized with rbp value for 10 times.According to the results , the incident is assumed not to be caused by any defect of the device.During dilating the target lesion which was massively calcified, sudden balloon rupture was occurred which assume to be due to patient's vessel condition.Patient's death was coorred after the procedure had been completed, and the causal relationship between the concerned device and the patien's death is unknown.Since there was no abnormality in the manufacturing record and the test result on retained sample from the same lot, it is assumed that the cause of patient's death is due to condition of patient / lesion.In the instructions for use of ikazuchi zero (3216-3) , 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.[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.

Event Description

Left coronary site: diffuse massively calcified arteriopathy.The common trunk is normal, without stenosis.The proximal anterior interventricular artery is the site of an intermediate stenosis of about 50%.The middle anterior interventricular artery presents a very tight stenosis (70-90%).The second marginal presents significant stenosis (50-70%).Right coronary: the proximal right coronary artery has an old c-type occlusion. partially collateralized right coronary occlusion without therapeutic use.Massively calcified proximal intermediate lad lesion then calcified lad 3 lesion.Ffr lad 0.75.So decision to approach proximal lad.Predilatation of the proximal anterior interventricular artery with ikazuchi zero balloon.Occlusive spiroid dissection of lad, lmt and distal embolus material on balloon rupture.Implantation of an active stent synergy megatron (mr) 4 mm x 8 mm (boston scientific) no.25845832 (direct stenting) at common trunk level in rescue.Then change of way first to femoral 7f.Complex and long lad clearance iterative balloons.Implantation of an orsiro 3.0 x 18 mm active stent (biotronik) no.01202750 in the area of the proximal anterior interventricular artery.Implantation of an active orsiro 2.5 x 18 mm stent (biotronik) no.11192364 in the area of the mid anterior interventricular artery.After final angiographic control, the artery of the average anterior interventricularis is free of significant lesions.The coronary flow is normal (timi 3).After final angiographic control, the proximal anterior interventricular artery is free of significative lesion.The coronary flow is normal (timi 3).Remains an isolated occlusion of the apical lad, flow restored.Conclusion: coronarography: tritroncular lesions.Lesion of the proximal anterior interventricular artery with ffr 0.75.Significant stenosis of the mid anterior interventricular artery.Significant stenosis of the second marginal.Chronic occlusion of the proximal right coronary artery.Angioplasty: successful angioplasty of the common trunk.Implantation of 1 active stent.Successful angioplasty of the middle anterior interventricular artery.Implantation of 1 active stent.Successful angioplasty of the proximal anterior interventricular artery.Implantation of 1 active stent.The patient was sent in icu following the successful procedure.Then the infarctus occurred and the patient died.Physician's comment by phone interview: this incident could happen with any kind of product and the death is related to this incident with the balloon rupture.

• Brand Name: KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)
• Type of Device: IKAZUCHI ZERO
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA CORPORATION OSAKA PLANT; 5-1-1; torikai-nishi; settsu-city, osaka 566-0 072; JA 566-0072
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 11374827
• MDR Text Key: 233441477
• Report Number: 3002808904-2021-00002
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: 505
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: ZE-20-300
• Device Lot Number: SR060456
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR