MAUDE Adverse Event Report: ASAHI INTECC USA, INC. PERIPHERAL GUIDE WIRE; WIRE, GUIDE, CATHETER

Model Number	ASTATO XS20
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.Fda safety report id# (b)(4).

• Brand Name: PERIPHERAL GUIDE WIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC USA, INC.
• MDR Report Key: 8687820
• Report Number: MW5087261
• Device Sequence Number: 14022040
• Product Code: DQX
• UDI-Device Identifier: 04547327088251
• UDI-Public: (01)04547327088251(17)210531(10)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/06/2019

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: ASTATO XS20
• Device Catalogue Number: GS1-128 0.014" / 0.008"X180CM
• Device Lot Number: 180615A251
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR