MAUDE Adverse Event Report: KANEKA CORPORATION I-ED COIL SYSTEM; NEUROVASCULAR EMBOLIZATION DEVICE AND VASCULAR EMBOLIZATION DEVICE

Model Number	393-030520
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Doctor was on the third i-ed coil (first two were framing coils) for the case and then felt something give pressure back and then took a picture and confirmed that we had ruptured the aneurysm.Doctor then asked to reverse protamine and then called for a 4x20 scepter balloon and 5x20cm axium coil to stop bleeding.Patients blood pressure started falling until balloon was inserted.Then patient was stabilized and was taken to neuro icu.Mfr report #3009761573-2025-00003.
Additional Manufacturer Narrative
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.The actual device was not returned and could not be investigated.We assume the cause of this as follows: the facility has not reported any defects in the product, and we determine that it was due to the patient's condition and procedure.However, since health hazards to the patient (rupture of aneurysm) occurred during inserting the i-ed coil, and the causal relationship between health hazards and the product cannot be completely ruled out, we judged the case is reportable.In the instructions for use of i-ed coil (2376-1) , we state the potential of known risk as below; [device failures, adverse events and complications] the following device failures, adverse events and complications may occur during the use of the i-ed coil.However, device failures, adverse events and complications are not limited to those listed below.Immediately take appropriate measures in the event that any abnormality occurs.2.Adverse events (1) death (3) injury to blood vessels or tissues, vessel wall dissection, blood vessel perforation, blood vessel rupture (5) bleeding, ischemia (7) stroke, cerebral infarction.The kaneka device has not been determined to have caused or contributed to the adverse event.This incident is being reported out of an abundance of caution.

• Brand Name: I-ED COIL SYSTEM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE AND VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18 nakanoshima, kita-ku; osaka-city, osaka 530-8 288; JA 530-8288
• MDR Report Key: 23511938
• Report Number: 2435151-2025-00016
• Device Sequence Number: 13167271
• Product Code: HCG
• UDI-Device Identifier: 04540778177321
• UDI-Public: 04540778177321
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2025
• Report Date (Section F): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 393-030520
• Device Catalogue Number: 101872
• Device Lot Number: KW094065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2025
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/10/2025