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

Model Number	AHW14R004J
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Sion blue delivered down rca with in stent restinosis.Long stent in place just distal to the ostium stopping just proximal to the pl.No issues getting through the calcium and tortuosity.Ivus was loaded on wire to investigate rca ostium.Ivus would not cross.At this time it was noticed that the sion blue wire had separated into the distal pl.Upon removing the wire it was observed that a second fragment was left behind in the distal rca.

• Brand Name: SION BLUE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12441458
• Report Number: 3004718255-2021-00236
• Device Sequence Number: 1245286
• Product Code: DQX
• UDI-Device Identifier: 04547327086240
• UDI-Public: (01)04547327086240(17)230731(10)200808A07A
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021
• Report Date (Section F): 09/08/2021

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 Expiration Date: 07/31/2023
• Device Model Number: AHW14R004J
• Device Catalogue Number: AHW14R004J
• Device Lot Number: 200808A07A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/03/2021
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Date Report Sent to FDA: 09/08/2021