MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. CHIKAI 008; NEUROVASCULAR GUIDE WIRE

Catalog Number	WAIN-CKI-008-200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation could not be performed because the affected device was discarded by the user facility.Lot history review revealed no anomaly relating to the reported event.No other similar product experience report was received from this lot.Based on the obtained information and outcome of manufacturing records review, it was presumed that anatomical conditions had likely contributed to the reported tip separation.Due to tortuous vessel, bending stress generated with wire manipulation would localize and therefore exceed the product design limit, leading the wire tip to be fractured.It was concluded that this event was not attributed to product quality.No capa will be taken.Instructions for use (ifu) states: warnings] ~ observe movement of this guide wire in the vessels.Before this guide wire is moved or torqued, the tip movement should be examined and monitored under fluoroscopy.Do not move or torque the guide wire without observing corresponding movement of the tip.Otherwise, the guide wire may be damaged and/or vessel trauma may occur.In addition, ensure that the distal tip of this guide wire and its location in the vessel are visible during manipulations of the guide wire.[malfunction and adverse effects] ~ damage such as separation.
Event or Problem Description
It was reported that the tip of an asahi chikai 008 guide wire broke off in the radicular artery during a spinal arteriovenous fistula (dural avf) embolization.The guide wire was advanced to the radicular artery via the t10 intercostal artery in order to deliver a microcatheter.When the guide wire was pulled back though the microcatheter without resistance, a distal 1-2 cm of the guide wire tip became detached inside the t10 radicular artery.The separated tip was not retrieved.There was no harm to the patient associating with this event.

• Brand Name: CHIKAI 008
• Common Device Name: NEUROVASCULAR GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer (Section G): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• Manufacturer Contact: yukako homma ; 3-100 akatsuki-cho; seto, aichi 489-0-071 ; JA 489-0071
• MDR Report Key: 12879758
• Report Number: 3003775027-2021-00190
• Device Sequence Number: 17231636
• Product Code: MOF
• UDI-Device Identifier: 04547327098120
• UDI-Public: (01)04547327098120(17)240229(10)210315A28A
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K141751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: WAIN-CKI-008-200
• Device Lot Number: 210315A28A
• 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: 11/12/2021
• Initial Report FDA Received Date: 11/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2021
• 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: Disability
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic