MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. FIELDER XT-A; GUIDE WIRE

Model Number	APW14R009S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The mid rca was heavily calcified and a dissection / re-entry technique was used to try and take the xta from the subintimal space back into the true lumen of the artery.During the re-entry the wire caught on calcium and the coils at the tip of the xta unwound.The wire was removed in its entirety and there was no adverse effect to the patient.
Event or Problem Description
The mid rca was heavily calcified and a dissection / re-entry technique was used to try and take the xta from the subintimal space back into the true lumen of the artery.During the re-entry the wire caught on calcium and the coils at the tip of the xta unwound.The wire was removed in its entirety and there was no adverse effect to the patient.

• Brand Name: FIELDER XT-A
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9176995
• Report Number: 3004718255-2019-00120
• Device Sequence Number: 1564644
• Product Code: DQX
• UDI-Device Identifier: 04547327088121
• UDI-Public: (01)04547327088121(17)220430(10)190515A11
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019
• Report Date (Section F): 10/09/2019

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: No Information
• Device Expiration Date: 04/30/2022
• Device Model Number: APW14R009S
• Device Catalogue Number: APW14R009S
• Device Lot Number: 190515A511
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/07/2019
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Date Report Sent to FDA: 10/09/2019