MAUDE Adverse Event Report: ASAHI INTECC CO LTD MINAMO; GUIDEWIRE

Catalog Number	AH14R026S
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The wire was in place in the coronary artery for percutaneous coronary stent placement.After stent deployed, wire attempted to be withdrawn and operator was met with resistance which was overcome when hydrophilic tip disconnected from wire and was retained in struts of stent.

• Brand Name: MINAMO
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC CO LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 24259111
• Report Number: 3004718255-2026-00002
• Device Sequence Number: 18541835
• Product Code: DQX
• UDI-Device Identifier: 04547327130745
• UDI-Public: (01)04547327130745(17)280430(10)250524A071
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/04/2026
• Report Date (Section F): 02/04/2026

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: AH14R026S
• Device Lot Number: 250524A071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/13/2026
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Date Report Sent to FDA: 02/04/2026