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

Model Number	AHW14R001S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Both sion wires got stuck in corsair pro microcatheter.Fragment came off while in patient and unable to remove, had to stop procedure and stent across.
Event or Problem Description
Both sion wires got stuck in corsair pro microcatheter.Fragment came off while in patient and unable to remove, had to stop procedure and stent across.
Event or Problem Description
Both sion wires got stuck in corsair pro microcatheter.Fragment came off while in patient and unable to remove, had to stop procedure and stent across.

• Brand Name: SION
• 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: 8877109
• Report Number: 3004718255-2019-00114
• Device Sequence Number: 290588
• Product Code: DQX
• UDI-Device Identifier: 04547327082624
• UDI-Public: (01)04547327082624(17)220228(10)190316A061
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 07/30/2019
• Report Date (Section F): 08/08/2019

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: 02/28/2022
• Device Model Number: AHW14R001S
• Device Catalogue Number: AHW14R001S
• Device Lot Number: 190316A061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2019
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 08/22/2019; 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: 08/08/2019