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

Catalog Number	502455
Medical Device Problem Codes	Peeled/Delaminated (1454); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the customer submitted images regarding wire fraying in the packaging of a.035 x 260 cm j tip 26 emerald guidewire where multiple areas of protruding filaments are seen.Additionally, irregular spacing between coil turns is present.It cannot be conclusively determined from the images whether the guidewire was still sealed within an unopened package at the time the condition was observed.There was no reported patient injury.The device is expected to be returned for evaluation.
Additional Manufacturer Narrative
As reported, the customer submitted images regarding wire fraying in the packaging of a.035 x 260 cm j tip 26 emerald guidewire where multiple areas of protruding filaments are seen.Additionally, irregular spacing between coil turns is present.It cannot be conclusively determined from the images whether the guidewire was still sealed within an unopened package at the time the condition was observed.There was no reported patient injury.Multiple attempts to obtain supplemental information were made; however, additional event details were not provided.The device was not returned for evaluation as anticipated.Two photos were attached to (b)(4) showing the pouch packaging of the product and the distal end of a guidewire.The images revealed slight kinking at the distal end of the guidewire along with a reddish thread of undetermined origin.It could not be confirmed whether the packaging was sealed, and no additional anomalies or notable details were observed.A product history record (phr) review of lot 35272186 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire- unraveled/stretched¿ and ¿guidewire- exposed braidwire/corewire¿ were not seen during the evaluation.The images revealed a kink to the distal end of the device.Additionally, the malfunction ¿guidewire- foreign material¿ was seen during the image review.The root cause cannot be determined with the available information.The event details do not suggest the device was used outside of the instructions for use.However, the available information, photo analysis and phr did not present 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.
Additional Manufacturer Narrative
A product history record (phr) review of lot 35272186 revealed no anomalies or non-conformances during the manufacturing and inspection processes that could be associated with the event reported.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
The device was not returned for evaluation as anticipated.

• Brand Name: EMERALD
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): CORDIS US CORP; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; butlersland new ross co.; wexford ; 7863138372
• MDR Report Key: 22352065
• Report Number: 1016427-2025-00050
• Device Sequence Number: 4825543
• Product Code: DQX
• UDI-Device Identifier: 10705032055031
• UDI-Public: (01)10705032055031(17)271231(10)35272186
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2025

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 Catalogue Number: 502455
• Device Lot Number: 35272186
• Was Device Available for Evaluation?: Yes
• 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: 06/03/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 09/04/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/04/2025; 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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: UNKNOWN.
• Patient Sex: Unknown