MAUDE Adverse Event Report: ASAHI INTECC REGALIA XS 1.0; GUIDE WIRE

Catalog Number	PAGP140300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Physican was working on the pedal loop with a quickcross and regailia xs wire.Wire got stuck and broke apart when removing the wire.30mm of the wire was left in the patient's leg.The procedure ended with the physicians ballooning the wire in the vessel.No attempt was made to remove due to the caliber size of the vessel.The patient was fine and discharged.

• Brand Name: REGALIA XS 1.0
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 22020904
• Report Number: 3004718255-2025-00380
• Device Sequence Number: 9504493
• Product Code: DQX
• UDI-Device Identifier: 04547327088312
• UDI-Public: (01)04547327088312(17)270531(10)240604A06F
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 05/14/2025
• Report Date (Section F): 05/14/2025

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: PAGP140300
• Device Lot Number: 240604A06F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/07/2025
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Date Report Sent to FDA: 05/14/2025