MAUDE Adverse Event Report: ASAHI INTECC TREASURE 12; GUIDE WIRE

Model Number	PAGH18M370
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The treasure unraveled during procedure.No patient injury reported and wire was removed from patient.I was not in the procedure so cannot provide detail on the case.*hospital indicated no patient injury.

• Brand Name: TREASURE 12
• 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: 16677597
• Report Number: 3004718255-2023-00293
• Device Sequence Number: 5377859
• Product Code: DQX
• UDI-Device Identifier: 04547327088275
• UDI-Public: (01)04547327088275(17)240831(10)210917A221
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/04/2023
• Report Date (Section F): 04/04/2023

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: 08/31/2024
• Device Model Number: PAGH18M370
• Device Catalogue Number: PAGH18M370
• Device Lot Number: 210917A221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/13/2023
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2023
• 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: 04/04/2023