MAUDE Adverse Event Report: ASAHI INTECC SILVERWAY; GUIDE WIRE

Catalog Number	SA0035N26S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Specific feedback on the two issues: the silverway entered the thyrocervical branch with left radial arterial access.Psa.Had to coil embolize.Delayed cabg.The silverway wire exited into branch or dissection plane resulting in delay of procedure.General feedback on the wire: wire is harder to control.Almost too lubricious.Lacks adequate tactile feedback.

• Brand Name: SILVERWAY
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 12829562
• Report Number: 3004718255-2021-00245
• Device Sequence Number: 4926066
• Product Code: DQX
• UDI-Device Identifier: 14547327121627
• UDI-Public: (01)14547327121627(17)240430(10)210507T23A
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/17/2021
• Report Date (Section F): 11/17/2021

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: 04/30/2024
• Device Catalogue Number: SA0035N26S
• Device Lot Number: 210507T23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/17/2021