MAUDE Adverse Event Report: ASAHI INTECC SION BLUE; GUIDEWIRE

Catalog Number	AHW14R104S
Medical Device Problem Codes	Material Fragmentation (1261); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sion blue placed in lad, 2nd sion blue to diag, balloon of ostial diag into lad, stent placed in ostial diag into lad, post dilation of ostial diagonal, plaque shift in lad, stent placed in lad with proximal edge of the stent slightly overlapping ostial diag, post dilate stent of lad, final picture, lad wire withdrawn without incident, diag wire pulled back and tip separation was noted, microcatheter was trapped in and advanced carefully over the unraveled wire, distal tip was unable to be fully captured, wire and microcatheter were pulled out as a unit.Wire was withdrawn in its entirety.No wire pieces were left behind.No harm to the patient.Discharged as normal.Notes: it does not appear that the affected wire was ever jailed behind a stent or had to re-cross a stent.The tip position of the diag wire never changed once it was initially positioned into the diag.The affected wire appeared to have a small loop in it for much of the case.

• Brand Name: SION BLUE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 23097361
• Report Number: 3004718255-2025-00394
• Device Sequence Number: 9321297
• Product Code: DQX
• UDI-Device Identifier: 04547327133012
• UDI-Public: (01)04547327133012(17)280331(10)250425A08F
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2025
• Report Date (Section F): 09/19/2025

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: AHW14R104S
• Device Lot Number: 250425A08F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/29/2025
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/19/2025