MAUDE Adverse Event Report: ASAHI INTECC GRAND SLAM; GUIDEWIRE

Catalog Number	AG141302
Medical Device Problem Codes	Calcified (1077); Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Grand slam was locked in calcium and removed.No patient injury.The wire was snared and removed from patient.

• Brand Name: GRAND SLAM
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): ASAHI INTECC; 3-100 akatsuki-cho; seto, aichi 489-0 071; JA 489-0071
• MDR Report Key: 20440315
• Report Number: 3004718255-2024-00341
• Device Sequence Number: 8267013
• Product Code: DQX
• UDI-Device Identifier: 04547327055857
• UDI-Public: (01)04547327055857(17)270131(10)240203A08F
• 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): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/14/2024
• Report Date (Section F): 10/14/2024

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: AG141302
• Device Lot Number: 240203A08F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/09/2024
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2024
• 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: 10/14/2024