MAUDE Adverse Event Report: ASAHI INTECC MINAMO; GUIDE WIRE

Model Number	AH14R026S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During pci, the "tip of the minamo wire" was broken and retained in the coronary artery.No additional details were known.I will follow up with account and will be on-site on may 17th.
Event or Problem Description
During pci, the "tip of the minamo wire" was broken and retained in the coronary artery.No additional details were known.I will follow up with account and will be on-site on may 17th.A minamo wire was attempted, but given calcification and severe tortuosity, was unable to cannulate the distal vessel.The severe tortuosity and calcification in the rca resulted in shearing of the minamo tip which was retained in the mid-rca at the site of the occlusion.

• Brand Name: MINAMO
• 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: 14367090
• Report Number: 3004718255-2022-00258
• Device Sequence Number: 12026507
• Product Code: DQX
• UDI-Device Identifier: 04547327130745
• UDI-Public: (01)04547327130745(17)221231(10)220125A261
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/11/2022
• Report Date (Section F): 05/11/2022

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: 12/31/2022
• Device Model Number: AH14R026S
• Device Catalogue Number: AH14R026S
• Device Lot Number: 220125A261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/28/2022
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 05/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Date Report Sent to FDA: 05/11/2022