MAUDE Adverse Event Report: ASAHI INTECC USA, INC. GRAND SLAM; WIRE, GUIDE, CATHETER

Model Number	AG141302
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: opened a 300cm.014 grand slam wire to the field.When the surgeon was using the wire, we noticed a defect in the wire under xray.The surgeon removed the wire from the patient, and we opened a new wire.From operative report: two proglide devices were deployed in the standard fashion for large-bore access closure.One failed and a 3rd device was required.

• Brand Name: GRAND SLAM
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC USA, INC.; 3002 dow avenue; ste. 212; tustin CA 92780
• MDR Report Key: 24002745
• Report Number: 24002745
• Device Sequence Number: 13392584
• Product Code: DQX
• UDI-Device Identifier: 04547327055857
• UDI-Public: (01)04547327055857
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2025
• Report Date (Section F): 12/22/2025

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 Model Number: AG141302
• Device Catalogue Number: AG141302
• Device Lot Number: 250513A09F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Date Report Sent to FDA: 12/22/2025