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

Catalog Number	WAIN-CKI-008-200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Physician advanced wire and headway duo microcatheter until physician commented that the wire was not torquing adequately.He removed the wire and the microcatheter and noticed the tip of the wire detached.Wire and tip are both available to return.Procedure was completed with another wire of same make and lot#.Patient was not affected.
Event or Problem Description
Physician advanced wire and headway duo microcatheter until physician commented that the wire was not torquing adequately.He removed the wire and the microcatheter and noticed the tip of the wire detached.Wire and tip are both available to return.Procedure was completed with another wire of same make and lot#.Patient was not affected.
Event or Problem Description
Physician advanced wire and headway duo microcatheter until physician commented that the wire was not torquing adequately.He removed the wire and the microcatheter and noticed the tip of the wire detached.Wire and tip are both available to return.Procedure was completed with another wire of same make and lot#.Patient was not affected.

• Brand Name: CHIKAI 008
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9326294
• Report Number: 3004718255-2019-00123
• Device Sequence Number: 19487012
• Product Code: DQX
• UDI-Device Identifier: 24547327098124
• UDI-Public: (01)24547327098124(17)220331(10)190402A58A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2019
• Report Date (Section F): 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: WAIN-CKI-008-200
• Device Lot Number: 190402A56A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/31/2019
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 11/17/2019; 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Date Report Sent to FDA: 11/15/2019