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

Catalog Number	390-0204
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	09/02/2023
Type of Reportable Event	Serious Injury
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 and consequent additional operation) occurred and have not recovered, and the causal relationship between health hazards and the product cannot be completely ruled out, we will submit mdr (30 days).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.(3) injury to blood vessels or tissues, vessel wall dissection, blood vessel perforation, blood vessel rupture (4) bleeding, ischemia (5) stroke, cerebral infarction.
Event or Problem Description
1st coil in the ica was implanted and during the deployment of the last 1cm of the 2x4 ss, the aneurysm ruptured.Noted a new catheter(headway 17) was used before the coil was deployed and no mention from the md that the coil was at fault.The same 2x4 ss was implanted three times prior with no incident with a 156 headway duo.Each of the three 1st attempts the last portion of the coil kicked out the 156 headway duo out of the aneurysm.The rupture occurred with the 4th attempt with the same 2x4 ss and the 1st time using the headway 17 catheter.One additional coil was placed, and the aneurysm was occluded.Patient was stable after another coil was given and coiling was complete.

• Brand Name: I-ED COIL SYSTEM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima, kita-ku; osaka-city, 530-8 288; JA 530-8288
• Manufacturer (Section G): KANEKA MEDIX CORPORATION KANAGAWA PLANT; 225-1; aza deguchi; ashigara-kami-gun yamakita, kanagawa 258-0 113; JA 258-0113
• Manufacturer Contact: joji sengoku ; 1-12-32; akasaka; minato-ku, tokyo 107-6-028 ; JA 107-6028
• MDR Report Key: 17752991
• Report Number: 3009761573-2023-00003
• Device Sequence Number: 15256492
• Product Code: HCG
• UDI-Device Identifier: 04540778176515
• UDI-Public: 04540778176515
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K192068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2023

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 390-0204
• Device Lot Number: KR033129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female