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

Model Number	PAGH143392
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While trying to penetrate this heavily calcified lad with an astato xs 20 guide wire with the support of the corsair pro xs microcatheter(#7662), the tip of the corsair pro xs broke off of the distal segment of the microcatheter and became affixed to the distal segment of the astato xs 20 guide wire.
Event or Problem Description
While trying to penetrate this heavily calcified lad with an astato xs 20 guide wire with the support of the corsair pro xs microcatheter(#7662), the tip of the corsair pro xs broke off of the distal segment of the microcatheter and became affixed to the distal segment of the astato xs 20 guide wire.

• Brand Name: ASTATO XS 20
• 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: 10463723
• Report Number: 3004718255-2020-00154
• Device Sequence Number: 16816196
• Product Code: DQX
• UDI-Device Identifier: 04547327088305
• UDI-Public: (01)04547327088305(17)220930(10)191010A021
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020
• Report Date (Section F): 08/27/2020

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: 09/30/2022
• Device Model Number: PAGH143392
• Device Catalogue Number: PAGH143392
• Device Lot Number: 191010A021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/21/2020
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/27/2020
• Supplement Report FDA Received Date: 08/27/2020
• 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: 08/27/2020