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

Catalog Number	502728
Medical Device Problem Codes	Fracture (1260); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the tip of a.035-inch straight 180 cm emerald diagnostic guidewire was at risk of detaching from the main wire shortly after initial insertion into the drain catheter.The device was used to remove a nephrostomy tube only, and this posed a significant safety concern that required immediate intervention to prevent potential harm to the patient.There was no reported patient injury.The device will not be returned for evaluation.
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 35273077 presented no issues during the manufacturing process that can be related to the reported event.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.
Additional Manufacturer Narrative
As reported, the tip of a.035-inch straight 180cm emerald diagnostic guidewire was at risk of detaching from the main wire shortly after initial insertion into the drain catheter, and the procedure was completed by removing the wire and completing nephrostomy tube removal.There was no reported patient injury.The device was not used for a chronic total occlusion, for highly tortuous vasculature, or for small side branches, and it was not exposed to a metal device.Torque control and tip response were compromised while using the guidewire.The product was inspected prior to use and appeared normal, with no problems noted during preparation and no damage to the packaging.The device was stored and prepared according to the instructions for use (ifu), and the user was trained in the use of the device.The non-sterile guidewire dgw.035 fc str ss 180cm ptfe was received coiled inside a clear plastic bag and was unpacked for visual inspection.The unit was thoroughly inspected and was found to exhibit a severe kinked condition with an unraveled coil wire exposing the core wire at the distal tip.Two additional kinks were observed on the guidewire body located approximately 20 cm and 23 cm from the distal end.No fractured condition or other outstanding anomalies were observed.The area with the severe kink was further evaluated using a vision system, which confirmed that the core wire was exposed due to the coil wire being overstretched beyond its intended mechanical limit.The observed kinked and unraveled conditions were consistent with excessive force applied to the guidewire.The core wire was visible but did not protrude from the coil wire, and no sharp edges were identified.The exact cause of the observed conditions could not be conclusively determined during the analysis, and the product analysis did not provide evidence to suggest that the conditions were related to a manufacturing or design process.A product history record (phr) review of lot 35273077 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿distal tip ¿ fractured¿ was not found during the product evaluation.Instead, the malfunction ¿guidewire ¿ exposed braidwire/corewire¿ was observed.The core wire was exposed due to the coil wire being overstretched beyond its intended mechanical limit.The observed kinked and unraveled conditions were consistent with excessive force applied to the guidewire.The product was inspected prior to use and appeared normal, with no problems noted during preparation and no damage to the packaging therefore, procedurally related factors cannot be excluded as a potential root cause.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.; 14021 nw 60 avenue; miami lakes, florida 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: 23626756
• Report Number: 1016427-2025-00089
• Device Sequence Number: 16025037
• Product Code: DQX
• UDI-Device Identifier: 10705032055727
• UDI-Public: (01)10705032055727(17)280630(10)35273077
• 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,Followup
• Report Date (Section B): 01/26/2026

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 Catalogue Number: 502728
• Device Lot Number: 35273077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/08/2025; 01/23/2026
• Initial Report FDA Received Date: 11/22/2025
• Supplement Report FDA Received Date: 01/05/2026; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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
• Patient Sex: Unknown