MAUDE Adverse Event Report: ASAHI INTECC SION BLUE; PTCA GUIDE WIRE

Model Number	N/A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Physcian comment according to nurse report given to me over the phone: "the wire completely frayed on me and its all mangled up" this is a very experienced sion blue user who has never encountered difficulties with the wire in the past.

• Brand Name: SION BLUE
• Common Device Name: PTCA GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 11008511
• Report Number: 3004718255-2020-00183
• Device Sequence Number: 13670399
• Product Code: DQX
• UDI-Device Identifier: 14547327086223
• UDI-Public: (01)14547327086223(17)230731(10)200808A03A
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2020
• Report Date (Section F): 12/14/2020

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: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: AHW12R004S
• Device Lot Number: 200808A03A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2020
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2020
• 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: 12/14/2020