MAUDE Adverse Event Report: ASAHI INTECC PROWATER; GUIDEWIRE

Model Number	AGH146000
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
When wire was entered into the body the physician noticed the separation of the wire.Removed and inserted second wire.Same separation.Removed and used different wire.Nothing left in body.

• Brand Name: PROWATER
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 10814431
• Report Number: 3004718255-2020-00168
• Device Sequence Number: 2908740
• Product Code: DQX
• UDI-Device Identifier: 04547327056120
• UDI-Public: (01)04547327056120(17)230630(10)200703A30A
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 11/03/2020
• Report Date (Section F): 11/09/2020

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: 06/30/2023
• Device Model Number: AGH146000
• Device Catalogue Number: AGH146000
• Device Lot Number: 200703A30A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/03/2020
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1