MAUDE Adverse Event Report: ASAHI INTECC ASTATO; GUIDE WIRE

Catalog Number	PAGH18M371
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Tip of astato 30 300 cm broke off while trying to manipulate the wire the body of a heavily calcified cto of right sfa.A 018 150 cm cxi straight tip catheter was used in addition to the astato 30 wire.The cxi catheter was able to be removed intact, but the tip of the astato 30 cm remained stuck in the occluded portion of the right sfa.

• Brand Name: ASTATO
• 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: 17726338
• Report Number: 3004718255-2023-00303
• Device Sequence Number: 17742297
• Product Code: DQX
• UDI-Device Identifier: 04547327088299
• UDI-Public: (01)04547327088299(17)260331(10)230330A151
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/24/2023
• Report Date (Section F): 09/11/2023

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 Expiration Date: 03/31/2026
• Device Catalogue Number: PAGH18M371
• Device Lot Number: 230330A151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/23/2023
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Date Report Sent to FDA: 09/11/2023