MAUDE Adverse Event Report: ASAHI INTECC MINAMO; GUIDE WIRE

Model Number	AH14R026S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.& staff noticed ribbon distal segment of wire having an uncovered portion 15mm back from distal tip of wire, preceded with that wire for case.Pre-dil stented -post dil.Completed case and everything removed.Nothing left in patient.They were discharged -no injury recovered in normal fashion.

• Brand Name: MINAMO
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, ja 489-0 071; JA 489-0071
• MDR Report Key: 9821829
• Report Number: 3004718255-2020-00138
• Device Sequence Number: 2871848
• Product Code: DQX
• UDI-Device Identifier: 14547327130742
• UDI-Public: (01)14547327130742(17)200831(10)190904A601
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2020
• Report Date (Section F): 03/11/2020

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: 08/31/2020
• Device Model Number: AH14R026S
• Device Lot Number: 190904A601
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/09/2020
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/11/2020