MAUDE Adverse Event Report: ASAHI INTECC PROWATERFLEX; GUIDE WIRE

Catalog Number	AGH147000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/05/2025
Type of Reportable Event	Death
Event or Problem Description
Details to follow as our sales rep will be onsite on (b)(6) 2025.At this moment, all he knows is that the tip of the prowater broke off in the left main and patient ended up dying.He will gather more information about lesion and other devices used when he picks up the wire.

• Brand Name: PROWATERFLEX
• 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: 21554263
• Report Number: 3004718255-2025-00375
• Device Sequence Number: 14613250
• Product Code: DQX
• UDI-Device Identifier: 04547327056311
• UDI-Public: (01)04547327056311(17)270930(10)241010A111
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2025
• Report Date (Section F): 03/07/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AGH147000
• Device Lot Number: 241010A111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/05/2025
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/07/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2025
• 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: Death
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/07/2025