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

Model Number	AG14M370
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The information that was shared to me was that the tip broke off after getting lodged/stuck in heavy calcium.The tip was visible and was subsequently stented in the wall of the vessel at the lesion.

• Brand Name: MIRACLEBROS 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: 13004557
• Report Number: 3004718255-2021-00247
• Device Sequence Number: 17352282
• Product Code: DQX
• UDI-Device Identifier: 04547327058148
• UDI-Public: (01)04547327058148(17)240229(10)210313A211
• 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): 12/14/2021
• Report Date (Section F): 12/14/2021

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: 02/29/2024
• Device Model Number: AG14M370
• Device Catalogue Number: AG14M370
• Device Lot Number: 210313A211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/13/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/14/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2021
• 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: 12/14/2021