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Catalog Number ZE-8-100P
Device Problem Fracture (1260)
Patient Problem Obstruction/Occlusion (2422)
Event Date 07/02/2021
Event Type  malfunction  
Event Description
Angioplasty failure of the distal anastomosis of the lima / lad bypass and anterior interventricular artery distal. Crossing the stenosis with a 1. 0x8 mm balloon but failure to withdraw this balloon, rupture of the carrier catheter and the distal end of the balloon became stuck in the distal lad which causes complete occlusion of the distal lad. The distal part of the balloon could not be retrieved, and was left inside patient body. The patient condition is stable.
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. 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. From the operational report, we confirmed that the balloon was dilated with 16 atm for twice and for total 23 seconds, which is exceeded rbp value 14 atm. We assume the cause of this as follows: factors that may contribute to the balloon/shaft break include, but are not limited to, during withdrawal of the catheter shaft after dilating the balloon, the distal part was stuck at the stenosis 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.
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Manufacturer (Section D)
nakanoshima, kita-ku
osaka-city, 530-8 288
JA 530-8288
MDR Report Key12717736
MDR Text Key281910677
Report Number3002808904-2021-00010
Device Sequence Number1
Product Code LOX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberZE-8-100P
Device Lot NumberSR011565
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/29/2021 Patient Sequence Number: 1