MAUDE Adverse Event Report: Asahi Intecc CO Ltd MINAMO; PTCA Guide Wire

Model Number	AH14R026S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asahi minamo guide wire was used for a percutaneous coronary intervention (pci) to treat an unspecified lesion in the coronary artery.The minamo guide wire was unraveled in the patient body.The physician tried to advance an ivus catheter over the minamo guide wire, but the ivus catheter got stuck.When the minamo guide wire was pulled out of the patient body, it was broken.It was informed that there was no adverse patient effect associated with this event and the patient was discharged.

• Brand Name: MINAMO
• Common Device Name: PTCA Guide Wire
• Manufacturer (Section D): Asahi Intecc CO Ltd; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 50934447
• Report Number: 3004718255-2026-00039
• Device Sequence Number: 21231977
• Product Code: DQX
• UDI-Device Identifier: 04547327130745
• 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
• Type of Report: Initial
• Report Date (Section B): 09/29/2026
• Report Date (Section F): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AH14R026S
• Device Lot Number: 260302A211
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/16/2026
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2026
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/29/2026