MAUDE Adverse Event Report: ASAHI INTECC, INC. ASTATO XS 20; GUIDEWIRE

Catalog Number	PAGH143392
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Femoral access was gained with a 5fr sheath.Images were taken of iliacs.A boston scientific pt extra support.014/300cm wire and (brand unknown) support catheter were inserted.Crossing of the lesion failed, so an astato xs 20 was exchanged, also unable to cross lesion, astato xs 20 tip broke off in the subintimal space of calcified lesion.An astato 30 was also exchanged, unable to cross.An abbott ht command es was exchanged and crossed lesion.A boston scientific sterling 5 x 20 balloon was used, the volcano ivus catheter was inserted for imaging, followed by a j & j smart control 8 x 60 stent with post dilatation using a boston scientific mustang 7 x 60 balloon.Patient was recovered and discharged in normal protocol.No complications were observed.

• Brand Name: ASTATO XS 20
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC, INC.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 23341665
• Report Number: 3004718255-2025-00397
• Device Sequence Number: 15396371
• Product Code: DQX
• UDI-Device Identifier: 04547327088305
• UDI-Public: (01)04547327088305(17)270430(10)240529A411
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/20/2025
• Report Date (Section F): 10/20/2025

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: PAGH143392
• Device Lot Number: 240529A411
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/06/2025
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/20/2025