MAUDE Adverse Event Report: ASAHI INTECC CO LTD PROWATER; PTCA GUIDE WIRE

Model Number	AGH146000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an asahi prowater guide wire was used for a percutaneous coronary intervention (pci) to treat a moderately calcified and mildly tortuous 75% or less stenosis in the ramus intermedius (ri).The prowater guide wire formed a loop at the proximal ri.An attempt was made to straighten the loop by pulling the guide wire.The tip of the prowater guide wire was detached and remained in the artery.A stent was deployed to embed the fragment against the vessel wall.It was informed that there was no adverse patient effect associated with this event and the patient was discharged.Mfr report #: 3003775027-2026-00140.

• Brand Name: PROWATER
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO LTD; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 25895619
• Report Number: 3004718255-2026-00031
• Device Sequence Number: 9790076
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)280331(10)250417A07A
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/16/2026
• Report Date (Section F): 07/21/2026

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: AGH146000
• Device Lot Number: 250417A07A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/22/2026
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/21/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/21/2026
• 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: Required Intervention; Disability
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/21/2026