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

Catalog Number	APW14R010S
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
These are the events as they were provided to the sales rep.Sales rep was not present during this event.The sion black was used to wire through freshly placed left main stent into the lcx.The goal was to dilate the stent struts and further support normal blood flow through stent into lcx.The lcx was a cto at the beginning of the procedure.Sales rep does not know if this was a new wire or if it had been used earlier in the procedure.Sales rep does not know the state of the lcx after revascularization or if any stenting that may have been done.The sion black navigated the stent struts and was guided down the lcx for an unknown distance.A rx coronary balloon was advanced over the sion black with the plan to pass through the struts and dilate the ostium.The balloon would not cross the struts and was removed, sales rep does not have information if it was inflated at any time.An attempt was then made to remove the sion black but it was stuck in the lcx.Force was used and the distal wire separated from the body at the junction of the radiopaque to the body of the wire.Attempts were made to retrieve the distal end of the wire using a micro snare but they were unsuccessful.Further access through the stent strut was deemed high risk and no further intervention was attempted.

• Brand Name: SION BLACK
• 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: 12329142
• Report Number: 3004718255-2021-00234
• Device Sequence Number: 4686639
• Product Code: DQX
• UDI-Device Identifier: 14547327089682
• UDI-Public: (01)14547327089682(17)240331(10)210401A131
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021
• Report Date (Section F): 08/16/2021

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: 03/31/2024
• Device Catalogue Number: APW14R010S
• Device Lot Number: 210401A131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/06/2021
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 08/16/2021