MAUDE Adverse Event Report: CORDIS US. CORP EMERALD; WIRE, GUIDE, CATHETER

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to system limitations, section h6 required to input type of investigation, investigation findings, and investigation conclusions for an initial report.Pending additional information to complete investigation.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, when threading a 5f infiniti cordis judkins left (jl) 4 catheter over a.035 260cm emerald j-tip guidewire, the physician noticed the guidewire was kinked and had fractured.There were no reported injuries to the patient.The device was stored and prepared according to the instructions for use (ifu).The wire was not removed from the dispenser by the distal floppy end, and the guidewire was not shaped during preparation.There was no indication of kinking prior to insertion.The guidewire was used in a cardio diagnostic vessel.There was no resistance or friction observed between the catheter and the emerald guidewire.The distal tip of the guidewire had fractured, but the fracture did not result in separation into two pieces.The procedure was completed using a new wire.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.Complaint conclusion: as reported, when threading a 5f infiniti cordis judkins left (jl) 4 catheter over a.035 260cm emerald j-tip guidewire, the physician noticed the guidewire was kinked and had fractured.There were no reported injuries to the patient.The device was stored and prepared according to the instructions for use (ifu).The wire was not removed from the dispenser by the distal floppy end, and the guidewire was not shaped during preparation.There was no indication of kinking prior to insertion.The guidewire was used in a cardio diagnostic vessel.There was no resistance or friction observed between the catheter and the emerald guidewire.The distal tip of the guidewire had fractured, but the fracture did not result in separation into two pieces.The procedure was completed using a new wire.The non-sterile guidewire dgw.035 fc j3mm 260cm tef was received coiled inside a clear plastic bag and unpacked for visual inspection.Examination identified a kinked condition at the distal tip.No other abnormalities or notable findings were observed.The exact cause of the observed distal tip kink could not be conclusively determined during analysis.Product evaluation did not identify evidence suggesting the kink was related to the manufacturing or design process.The reported ¿guidewire ¿ fractured¿ was not found during the product evaluation.However, the reported ¿guidewire ¿ kinked/bent¿ was seen.The exact cause of the event cannot be found.There was no indication of kinking prior to insertion therefore, procedural and handling factors cannot be excluded.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent of making the user aware of the risks.According to the instructions for use (ifu), ¿if strong resistance is met during manipulation, discontinue the procedure and determine the cause of resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter and guidewire.¿ based on the available information and product analysis, there is no evidence to suggest the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: EMERALD
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; 7863138372
• MDR Report Key: 23957023
• Report Number: 1016427-2026-00001
• Device Sequence Number: 12165200
• Product Code: DQX
• UDI-Device Identifier: 10705032055031
• UDI-Public: (01)10705032055031(17)280731(10)35273938
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K864058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: N/A
• Device Catalogue Number: 502455
• Device Lot Number: 35273938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5F INFINITI CORDIS JUDKINS LEFT (JL) 4
• Patient Sex: Unknown