MAUDE Adverse Event Report: ASAHI INTECC SOFT; GUIDE WIRE

Model Number	AG141300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
First two soft wires used both with the same lot number experienced a distal core fracture observed on x-ray.A third soft wire was used but from a different lot number.It was fine.Patient outcome was good.

• Brand Name: SOFT
• 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: 14990022
• Report Number: 3004718255-2022-00265
• Device Sequence Number: 1584484
• Product Code: DQX
• UDI-Device Identifier: 04547327056229
• UDI-Public: (01)04547327056229(17)250131(10)220208A161
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/12/2022
• Report Date (Section F): 07/12/2022

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
• Device Expiration Date: 01/31/2025
• Device Model Number: AG141300
• Device Catalogue Number: AG141300
• Device Lot Number: 220208A161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/28/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/12/2022