MAUDE Adverse Event Report: ASAHI INTECC MIRACLEBROS; GUIDE WIRE

Model Number	AG14M060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
This is an exert from the procedural note describing the fracture of a ''miracle brother wire'.Approximately 13.2 mm of wire remained behind.While "trying to penetrate the distal cap of a coronary vessel with a miracle brothers wire, it appeared as though the wire had gone subintimal on retrograde injection.When the miracle brother wire was attempted to be retracted there was resistance so initial attempts were made to remove the wire as a unit with the turnpike microcatheter and then the xb 3.5 guide catheter until the no more resistance was noted but on angiography it appeared that the floppy tip of the miracle brother wire had fractured into the subintimal space which was confirmed on orthogonal and dual angiographies.As the wire was removed from the body it was confirmed on gross examination that it was the floppy tip of the wire which had fractured and was left in the subintimal space.As there was no change in the clinical status of the patient with intact hemodynamics, stable ekg findings, and lack of worsening chest pain we decided against snaring the fractured wire tip due to the risks vs benefits as it was in the subintimal space and unlikely to become thrombogenic in an already cto (chronic total occlusion) vessel.Additionally, given adequate collateral r to l (right to left) flow we decided against proceeding further at revascularizing the cto due to risk of embolizing the fractured wire and will medically manage patient instead".

• Brand Name: MIRACLEBROS
• 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: 17195704
• Report Number: 3004718255-2023-00299
• Device Sequence Number: 20657969
• Product Code: DQX
• UDI-Device Identifier: 04547327056083
• UDI-Public: (01)04547327056083(17)230630(10)200717A051
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2023
• Report Date (Section F): 06/23/2023

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: 06/30/2023
• Device Model Number: AG14M060
• Device Catalogue Number: AG14M060
• Device Lot Number: 200717A051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/31/2023
• Device Age: 34 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/23/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/23/2023