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

Model Number	AG14M070
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/03/2019
Type of Reportable Event	Serious Injury
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.
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: GUIDE WIRE
• Manufacturer (Section D): ASAHI INTECC CO., LTD.; 3-100 akatsuki-cho; seto, 489-0 071; JA 489-0071
• MDR Report Key: 9246852
• Report Number: 3004718255-2019-00121
• Device Sequence Number: 19376238
• Product Code: DQX
• UDI-Device Identifier: 04547327058131
• UDI-Public: (01)04547327058131(17)210430(10)180512A021
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019
• Report Date (Section F): 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: AG14M070
• Device Catalogue Number: AG14M070
• Device Lot Number: 180512A021
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/23/2019
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 89
• Date Report Sent to FDA: 10/28/2019