MAUDE Adverse Event Report: ASAHI INTECC. CO., LTD ASTATO XS 20; PERIPHERAL GUIDE WIRE

Model Number	PAGH143092
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
After removing the guide wire from the pt's artery, we noticed the wire was frayed and the tip appeared to be broken.
Event or Problem Description
After removing the guide wire from the pt's artery, we noticed the wire was frayed and the tip appeared to be broken.

• Brand Name: ASTATO XS 20
• Common Device Name: PERIPHERAL GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC. CO., LTD; 3-100 akatsuki-cho; seto, 48900 71; JA 4890071
• MDR Report Key: 8839481
• Report Number: 3004718255-2019-00112
• Device Sequence Number: 2548231
• Product Code: DQX
• UDI-Device Identifier: 04547327088251
• UDI-Public: (01)04547327088251(17)210531(10)180615A251
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2019
• Report Date (Section F): 01/13/2020

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: 05/31/2021
• Device Model Number: PAGH143092
• Device Catalogue Number: PAGH143092
• Device Lot Number: 180615A251
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/13/2020