MAUDE Adverse Event Report: ASAHI INTECC SION BLUE; GUIDE WIRE

Model Number	AHW14R104S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented to the cath lab in cardiac arrest and resuscitated.Dr.(b)(6) was wiring the calcified lad when the event occurred.Dr.(b)(6) said that there was no resistance when pulling back on the wire and it smoothly came out leaving behind the tip.The tip of a sion blue came apart in a coronary artery.The patient went for bypass surgery and is doing well.
Event or Problem Description
The patient presented to the cath lab in cardiac arrest and resuscitated.Dr.(b)(6) was wiring the calcified lad when the event occurred.Dr.Kim said that there was no resistance when pulling back on the wire and it smoothly came out leaving behind the tip.The tip of a sion blue came apart in a coronary artery.The patient went for bypass surgery and is doing well.

• Brand Name: SION BLUE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 14246336
• Report Number: 3004718255-2022-00256
• Device Sequence Number: 4719042
• Product Code: DQX
• UDI-Device Identifier: 04547327133012
• UDI-Public: (01)04547327133012(17)241130(10)211206A16A
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2022
• Report Date (Section F): 04/28/2022

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: 11/30/2024
• Device Model Number: AHW14R104S
• Device Catalogue Number: AHW14R104S
• Device Lot Number: 211206A16A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/20/2022
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/29/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 05/13/2022
• 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; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male
• Date Report Sent to FDA: 04/28/2022