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

Model Number	AHW14R004J
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure was going well.Wire inserted correctly with no problem.Intervention performed and completed with no issues.Wire was being removed and radiographically showed the wire was being stretched, unraveling, physician carefully manipulated the wire and it was removed entirely.Wire retained with packaging.Fda safety report id (b)(4).

• Brand Name: ASAHI INTECC
• Common Device Name: SION BLUE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi, 489-0 071; JA 489-0071
• MDR Report Key: 10099233
• Report Number: 3004718255-2020-00142
• Device Sequence Number: 14130004
• Product Code: DQX
• UDI-Device Identifier: 04547327086240
• UDI-Public: (01)04547327086240(17)220930(10)191002A64A
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/28/2020
• Report Date (Section F): 05/28/2020

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: 09/30/2022
• Device Model Number: AHW14R004J
• Device Catalogue Number: AHW14R004J
• Device Lot Number: 191002A64A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/26/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 66
• Date Report Sent to FDA: 05/28/2020