MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUIDE WIRE

Model Number	AGH146000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
During heart cath on (b)(6) 2023 balloon angioplasty was done with lesion opening up.Intravascular ultrasound was done to assess prior stent and it was noted distal edge of prowater wire had dislodged into a small vessel at the very distal part of the high oml.Attempted to snare it unsuccessful.Consulted with surgeon and peers and decision made to not proceed with any intervention to remove the wire either endovascularly or surgically.Foreign body left in patient.

• 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: 16534899
• Report Number: 3004718255-2023-00289
• Device Sequence Number: 6388769
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)250831(10)220916A16A
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/13/2023
• Report Date (Section F): 03/13/2023

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 Expiration Date: 08/31/2025
• Device Model Number: AGH146000
• Device Catalogue Number: AGH146000
• Device Lot Number: 220916A16A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2023
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Date Report Sent to FDA: 03/13/2023