MAUDE Adverse Event Report: ASAHI INTECC CO., LTD. MIRACLEBROS 12; WIRE, GUIDE, CATHETER

Model Number	AG14M070
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patient underwent a cardiac catheterization for an rca pci.Multiple attempts were made to open the blockage.During this process, a wire was unable to be removed for the rca.Multiple snares were deployed to remove the wire, however each attempt unsuccessful.Finally a radial jaw was use to pull the wire.Wire broke and was removed from the patient's radial artery.A fragment of the wire remains in the patient's rca.

• Brand Name: MIRACLEBROS 12
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3002 dow ave suite 212; tustin CA 92780
• MDR Report Key: 9202192
• Report Number: 9202192
• Device Sequence Number: 3107161
• Product Code: DQX
• UDI-Device Identifier: 04547327058131
• UDI-Public: (01)04547327058131
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/04/2019
• Report Date (Section F): 10/04/2019

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: AG14M070
• Device Lot Number: 180512A021
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 89
• Date Report Sent to FDA: 10/04/2019