MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. FIEDLER XT; GUIDE WIRE

Model Number	AGP140002
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Wire tip broke off when physician was trying to support balloon and catheter kept coming out of vessel.Device retrieved.

• Brand Name: FIEDLER XT
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 9803036
• Report Number: 3004718255-2020-00135
• Device Sequence Number: 18996097
• Product Code: DQX
• UDI-Device Identifier: 04547327072854
• UDI-Public: (01)04547327072854(17)210630(10)180710A021
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/04/2020
• Report Date (Section F): 03/06/2020

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: 06/30/2021
• Device Model Number: AGP140002
• Device Catalogue Number: AGP140002
• Device Lot Number: 180710A021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Was the Report Sent to FDA?: Yes
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 03/06/2020