MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUIDE WIRE

Model Number	AGH146000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Type of procedure-other devices used-lesion information - diagnostic cath -lhb w/wo lv, ivus single vessel, interventional catheterization - single de stent, cath adj dx - peripheral ivus addl vessel.Level of disease-calcium etc[?].Lesion in true ramus arising from the lm.99% stenosis in ostial ri with timi2 flow concerning for plaque rupture.Patient harm - no harm detected.Device able to be returned? no.Mdr report #: mw5117196 [initial reporter: (b)(6) (nurse)].[describe event or problem].During interventional cardiac procedure, prowater wire used in an attempt to place stent.When the prowater wire was protracted, it was noted to have come back and the tip of the wire was seen embolized to the distal ramus.The stent remained partially in the lm.Given the nonobstructive lm disease, further maneuvers were felt to be unsafe.The decision was made to leave the ri as a ptca alone.Given the wire fragment was very distal, attempts to snare the fragment were felt to be high risk for causing ischemia and vessel injury.It is estimated that the retained fragment measures approximately 2.5 cm.No identified adverse outcomes to date.Patient discharged to home on (b)(6) 2023.

• Brand Name: PROWATER
• 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: 16942839
• Report Number: 3004718255-2023-00298
• Device Sequence Number: 12515835
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)251130(10)221207A32A
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/16/2023
• Report Date (Section F): 05/16/2023

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: 11/30/2025
• Device Model Number: AGH146000
• Device Catalogue Number: AGH146000
• Device Lot Number: 221207A32A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/03/2023
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2023
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/16/2023