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

Model Number	AHW14R104S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The distal tip of the wire fractured and was retained in the patient, requiring surgical intervention.This is all the information i have at the moment.Customer stated that the product is availabe for return.
Event or Problem Description
The distal tip of the wire fractured and was retained in the patient, requiring surgical intervention.This is all the information i have at the moment.Customer stated that the product is "available" for return.

• 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: 16792396
• Report Number: 3004718255-2023-00295
• Device Sequence Number: 12207575
• Product Code: DQX
• UDI-Device Identifier: 04547327133012
• UDI-Public: (01)04547327133012(17)241231(10)220105A08A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023
• Report Date (Section F): 04/21/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Model Number: AHW14R104S
• Device Catalogue Number: AHW14R104S
• Device Lot Number: 220105A08A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/14/2023
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 05/08/2023
• 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: Other
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White
• Date Report Sent to FDA: 04/21/2023