MAUDE Adverse Event Report: ASAHI INTECC SION BLACK; GUIDEWIRE

Catalog Number	APW14R010S
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Wiring through a septal branch, the sion black tip unraveled and left a piece distal in the septal branch.Patient was ok and right was crossed and stented.Piece left in distal septal branch.

• Brand Name: SION BLACK
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 20584404
• Report Number: 3004718255-2024-00342
• Device Sequence Number: 8650022
• Product Code: DQX
• UDI-Device Identifier: 04547327089685
• UDI-Public: (01)04547327089685(17)270430(10)240507A161
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/31/2024
• Report Date (Section F): 10/31/2024

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 Catalogue Number: APW14R010S
• Device Lot Number: 240507A161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/16/2024
• Device Age: 5 MO
• Date Report to Manufacturer: 10/31/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2024
• 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 Sex: Male
• Date Report Sent to FDA: 10/31/2024