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

Model Number	AHW14R004S
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During a complicated chronic total occlusion coronary procedure, one of the interventional wires became sheared off and a small flexible portion remains in the patients septal vessel.

• Brand Name: ASAHI SION BLUE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3002 dow ave suite 212; tustin CA 92780
• MDR Report Key: 8280904
• Report Number: 8280904
• Device Sequence Number: 2056999
• Product Code: DQX
• UDI-Device Identifier: 04547327086226
• UDI-Public: (01)04547327086226
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 01/04/2019
• Report Date (Section F): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AHW14R004S
• Device Catalogue Number: AHW14R004S
• Device Lot Number: 180525A05A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Weight: 103
• Date Report Sent to FDA: 01/04/2019