MAUDE Adverse Event Report: ASAHI INTECC GRAND SLAM; GUIDE WIRE

Catalog Number	AG141002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.(b)(6) was attempting to advance the stent into a heavy calcified circumflex coronary artery through an 8f ebu with 2 asahi grand slam wires and a guidzilla micro cath.The curvature was acute.There was tension and resistance, therefore, when dr.(b)(6) attempted to pull the stents back and reposition, the stents dislodged from the stent system, resulting both wires broke off into the lcx coronary artery.He captured the stent and stented the two pieces of grand slam wires in place.The case was finished, and no harm to the patient was reported.

• Brand Name: GRAND SLAM
• 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: 21289019
• Report Number: 3004718255-2025-00369
• Device Sequence Number: 9355430
• Product Code: DQX
• UDI-Device Identifier: 04547327055833
• UDI-Public: (01)04547327055833(17)270531(10)240601A03F
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/31/2025
• Report Date (Section F): 01/31/2025

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: AG141002
• Device Lot Number: 240601A03F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/14/2025
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• 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: 01/31/2025