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

Model Number	AHW14R101S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asahi sion guide wire was used during a percutaneous coronary intervention (pci) to treat a modelately calcified lesion in the proximal left anterior descending artery (lad).During the removal of the sion guide wire, the sion guide wire entered a subintimal space at the distal edge of the stent and was entrapped.The coil of the sion guide wire was unwound and fractured.An attempt was made to advance an unspecified microcatheter to the wire tip to facilitate retrieval; however, the attempt was unsuccessful.A terumo runthrough guide wire was advanced into the vessel and an unspecified 2.0mm balloon catheter was inflated across the affected segment.The microcatheter was advanced over the sion guide wire.Inspection revealed that the fracture had occurred only at the extreme distal tip of sion guide wire, and the remainder of the sion guide wire was removed intact.Post-intervention angiography showed that the wire fragment was trapped by the newly deployed stent.It was informed that there was no adverse patient effect associated with this event and the patient was dischagrged in stable condition.Mfr report #: 3003775027-2026-00161.

• Brand Name: ASAHI SION
• 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: 50164779
• Report Number: 3004718255-2026-00035
• Device Sequence Number: 20159995
• Product Code: DQX
• UDI-Device Identifier: 04547327132985
• UDI-Public: (01)04547327132985(17)281231(10)260110A04F
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2026
• Report Date (Section F): 08/06/2026

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: AHW14R101S
• Device Lot Number: 260110A04F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2026
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/06/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/06/2026