MAUDE Adverse Event Report: Asahi Intecc CO Ltd Astato XS 20; Peripheral Guide Wire

Model Number	PAGH143392
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a percutaneous transluminal angioplasty (pta) was performed for a chronic total occlusion (cto) with moderately calcified fibrous cap of approximately 2cm in length in the mid anterior tibial artery (mid at).An asahi astato xs 20 guide wire was advanced to the fibrous cap and torqued to penetrate the cto, when the guide wire lodged in the cap.When the astato xs 20 guide wire was removed, the wire tip was found left in the cto.Additional attempts were made to cross the cto with other guide wires but failed.The procedure was aborted at that point.It was informed that there was blood flow to the foot through the posterior tibial artery, while the at remained occluded.Mfr report #: 3003775027-2026-00147.

• Brand Name: Astato XS 20
• Common Device Name: Peripheral Guide Wire
• Manufacturer (Section D): Asahi Intecc CO Ltd; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 50086104
• Report Number: 3004718255-2026-00032
• Device Sequence Number: 18643475
• Product Code: DQX
• UDI-Device Identifier: 04547327088305
• UDI-Public: (01)04547327088305(17)280430(10)250507A221
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 07/30/2026
• Report Date (Section F): 07/30/2026

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: PAGH143392
• Device Lot Number: 250507A221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/08/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2026
• 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
• Patient Age: 86 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/30/2026