MAUDE Adverse Event Report: ASAHI INTECC GAIA SECOND; GUIDE WIRE

Model Number	AHW14R008P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Gaia second broke off at hinge point in subintimal layer of rca.The rest of the wire was removed cleanly from the coronary.Physician stated it was because he "overmanipulated the wire" and he "did not remove it when it was beginning to fatigue.".

• Brand Name: GAIA SECOND
• 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: 15871626
• Report Number: 3004718255-2022-00282
• Device Sequence Number: 17445569
• Product Code: DQX
• UDI-Device Identifier: 04547327094702
• UDI-Public: (01)04547327094702(17)250531(10)220615A501
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2022
• Report Date (Section F): 11/28/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: AHW14R008P
• Device Catalogue Number: AHW14R008P
• Device Lot Number: 220615A501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/17/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2022
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 11/28/2022