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

Model Number	N/A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Two sion blue wires fractured during this procedure.According to cath tech they had issues seeding the jr4 guide into ostium.She showed me picture of both the guideliner and ptca balloon and they looked mangled after being removed from the body.
Event or Problem Description
Two sion blue wires fractured during this procedure.According to cath tech they had issues seeding the jr4 guide into ostium.She showed me picture of both the guideliner and ptca balloon and they looked mangled after being removed from the body.

• 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: 11127823
• Report Number: 3004718255-2020-00193
• Device Sequence Number: 14286493
• Product Code: DQX
• UDI-Device Identifier: 04547327086226
• UDI-Public: (01)04547327086226(17)230630(10)200709A45A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/21/2020
• Report Date (Section F): 01/06/2021

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: AHW14R004S
• Device Lot Number: 200709A45A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/17/2022
• 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: Hospitalization
• Patient Age: 70 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/06/2021