MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. REGALIA XS 1.0; GUIDE WIRE

Model Number	PAGP140300
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The coating at the end was shredded after entering the popliteal.
Event or Problem Description
The coating at the end was shredded after entering the popliteal.

• Brand Name: REGALIA XS 1.0
• 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: 8924125
• Report Number: 3004718255-2019-00116
• Device Sequence Number: 10817092
• Product Code: DQX
• UDI-Device Identifier: 04547327088312
• UDI-Public: (01)04547327088312(17)220228(10)190312A221
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/17/2019
• Report Date (Section F): 08/22/2019

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: 02/28/2022
• Device Model Number: PAGP140300
• Device Lot Number: 190312A221
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/17/2019
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 02/12/2020
• 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: 08/22/2019