MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. ASAHI SION BLACK; WIRE, GUIDE, CATHETER

Model Number	APW14R010S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Wire tip came off while navigating stent struts.Manufacturer response for wire, guide, catheter, asahi sion black (per site reporter).Good follow-up.

• Brand Name: ASAHI SION BLACK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3002 dow ave suite 212; tustin CA 92780
• MDR Report Key: 12405438
• Report Number: 12405438
• Device Sequence Number: 12012702
• Product Code: DQX
• UDI-Device Identifier: 14547327089682
• UDI-Public: (01)14547327089682(17)240331(10)210401A131
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/13/2021
• Report Date (Section F): 08/13/2021

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: Health Professional
• Device Model Number: APW14R010S
• Device Lot Number: 210401A131
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/13/2021