MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. GAIA THIRD; GUIDE WIRE

Model Number	AHW14R011P
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Patient is stable and no known effects from case.Md states case was very difficult and vessel was very calcified.Gaia 3 was being used to cross lesion when he felt like the tip broke.Md said he is sure all the wire came out of vessel and feels like spring coil held tip of wire during removal.Md states the vessel was so hard with calcium that several other products(non-asahi), micro catheters and wires also came out damaged.

• Brand Name: GAIA THIRD
• 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: 10498208
• Report Number: 3004718255-2020-00160
• Device Sequence Number: 16939601
• Product Code: DQX
• UDI-Device Identifier: 04547327094788
• UDI-Public: (01)04547327094788(17)230131(10)200221A051
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2020
• Report Date (Section F): 09/06/2020

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: 01/31/2023
• Device Model Number: AHW14R011P
• Device Catalogue Number: AHW14R011P
• Device Lot Number: 200221A051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/31/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Date Report Sent to FDA: 09/06/2020