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

Catalog Number 390-0204

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2020

Event Type  Injury  

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 returned product is unraveled and in a terrible state, and it is our view that it is caused by the procedure.The following is stated in the package insert to alert people.[precautions] important basic precautions: insert and pull back this product slowly.Causes damage to blood vessels and damage to this product.

Event Description

Coil embolism in a patient waiting for vapica lesion (unruptured).When the doctor tried to insert the i-ed coil 2쳌~40mm (the product) by coil embolization with a stent, the tip of the microcatheter sl-10 came out of the aneurysm.Therefore, when the product was collected without being placed, the coil part was unraveled.After the coil was recovered, another stent was placed and the case was completed.The product was returned to us.When the actual product was investigated, it was found that the unraveled coil was cut and the tip side was missing.

• Brand Name: I-ED COIL SYSTEM
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): KANEKA CORPORATION; 2-3-18; nakanoshima,kita-ku; osaka, osaka 53082 88; JA 5308288
• Manufacturer Contact: tamiji fujimoto ; 2-3-18; nakanoshima, kita-ku; osaka, osaka 530-8-288 ; JA 530-8288
• MDR Report Key: 10081967
• MDR Text Key: 194331460
• Report Number: 3009761573-2020-00011
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 390-0204
• Device Lot Number: KR010224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2020
• 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): Other