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

Model Number	AHW14R104S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(6) 2022 with dr (b)(6).The radiopaque tip just tears apart and he left the distal part in the distal rca.He tried to removed but he couldn't.

• 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: 15237592
• Report Number: 3004718255-2022-00271
• Device Sequence Number: 4900258
• Product Code: DQX
• UDI-Device Identifier: 04547327133012
• UDI-Public: (01)04547327133012(17)250228(10)220226A59A
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 08/16/2022
• Report Date (Section F): 08/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: AHW14R104S
• Device Catalogue Number: AHW14R104S
• Device Lot Number: 220226A59A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/03/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 97 KG
• Date Report Sent to FDA: 08/16/2022