MAUDE Adverse Event Report: ASAHI INTECC SION BLACK; GUIDE WIRE

Catalog Number	APW14R310S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Delivered the wire with no issue through an occluded sfa stent.There is a chance the wire went through a stent strut but the balloons passed with no issue.Upon removing the wire, she noticed the end had appeared to have sheared off.No adverse effect to patient.Additional information: 1) it was speculated earlier in the case that the wire may have been through a stent strut because a catheter couldn't advance passed a certain spot.A small balloon was inflated and then there was no issue moving forward.Md did not mention any resistance to the wire upon removal.2) the fragment that was sheared off from the wire was not retrieved from the body 3) the procedure was finished as planned and was a success.4) the procedure was done with success in an obl.I believe the patient was sent home after a few hours of bedrest.

• Brand Name: SION BLACK
• 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: 22040357
• Report Number: 3004718255-2025-00381
• Device Sequence Number: 9095705
• Product Code: DQX
• UDI-Device Identifier: 04547327089708
• UDI-Public: (01)04547327089708(17)270630(10)240715A181
• 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): 05/16/2025
• Report Date (Section F): 05/16/2025

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 Catalogue Number: APW14R310S
• Device Lot Number: 240715A181
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2025
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2025
• 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: 05/16/2025