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

Model Number	AG141302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
I was in a case today where a grandslam 300cm wire was used and we noticed immediately that the end of the wire appeared to be broken or fractured.There was a gap in the radiopaque band.The wire was introduced through a corsair pro xs 150.The wire was removed intact, and i have the wire to send in.

• 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: 16941974
• Report Number: 3004718255-2023-00297
• Device Sequence Number: 3301192
• Product Code: DQX
• UDI-Device Identifier: 04547327055857
• UDI-Public: (01)04547327055857(17)250930(10)221029A241
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/16/2023
• Report Date (Section F): 05/16/2023

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: 09/30/2025
• Device Model Number: AG141302
• Device Catalogue Number: AG141302
• Device Lot Number: 221029A241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2023
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/16/2023