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

Catalog Number	502455
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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, the inner packaging for a.035 260cm j-tip emerald diagnostic guidewire was found damaged when the product was unpacked.There were no reported injuries to the patient.Additional information was requested but was not provided.The device was returned.Addendum: two devices were returned for evaluation.Both devices have inner packaging damage that compromises the device sterility.
Additional Manufacturer Narrative
After further review of additional information received.Complaint conclusion: as reported, the inner packaging for a.035 260cm j-tip emerald diagnostic guidewire was found damaged when the product was unpacked.There were no reported injuries to the patient.Additional information was requested but was not provided.Two non-sterile ¿dgw.035 fc j3mm 260cm tef guidewires were received inside the original packaging with the back of the pouch torn.They were evaluated under 2024-07425-1 (device 1) and 2024-07425-2 (device 2).Device two was inspected with a vision system, which presented evidence of elongations.These types of damages are commonly caused during the interaction of the material with an unknown sharp object causing mechanical damage.Therefore, it is assumed that the surface of the back of the pouch was induced to a force that exceeded the material yield strength prior to tearing.It appears that the external surface was torn by an interaction with a sharp object that was not part of the device.No other anomalies were observed.The failures reported by the customer as ¿packaging/pouch/box~damaged-inner package¿ and ¿packaging/pouch/box~ compromised sterility- sterile barrier breached¿ was confirmed for device 1 (2024-07425-1) and the failure ¿packaging/pouch/box~ compromised sterility- sterile barrier breached¿ was confirmed for device 2 (2024-07425-2).The returned units presented with torn conditions on the back of the pouch and the sterile barrier was breached.The exact cause of the observed damage could not be conclusively determined during the analysis.Storage or handling factors may be an underlying 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 to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use if package is open or damaged.¿ based on the available information, there is no indication that 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: 19797894
• Report Number: 1016427-2024-00025
• Device Sequence Number: 7096453
• Product Code: DQX
• UDI-Device Identifier: 10705032055031
• UDI-Public: (01)10705032055031(17)250630(10)35265202
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 502455
• Device Lot Number: 35265202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: ANGIOGRAPHIC CATHETER.; ANGIOGRAPHIC GUIDEWIRE.; GUIDE CATHETER.; SHEATH.
• Patient Sex: Unknown