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	04/20/2024
Type of Reportable Event	Malfunction
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: product evaluation revealed two devices were returned and there is a torn condition on the inner packaging compromising their sterility.
Additional Manufacturer Narrative
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.Two devices were returned for analysis and were evaluated under 2024-07423-1 and 2024-07423-2.During visual analysis, the seal of the pouch was noted to be intact.A torn condition was observed on the back of the pouch that is compromising the sterility.Sem analysis was not performed because the damages associated with the torn condition on the pouch are visible with the magnification obtained with a vision system.The torn material presents evidence of elongations.A product history record (phr) review of lot 35265205 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box~compromised sterility-sterile barrier breached¿ was confirmed for both devices.Additionally, the event reported against the first device ¿packaging/pouch/box~damaged-inner package¿ was also confirmed.Both units presented with a torn condition on the back of the pouch.Elongations are commonly caused by an interaction with a sharp object, which causes mechanical damage.Therefore, it is assumed that the surface of the back of the pouch was induced to a force (likely an unknown sharp object) that exceeded the material yield strength prior to the tearing.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 and the phr review, 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 ; EI ; 7863138372
• MDR Report Key: 19764943
• Report Number: 1016427-2024-00023
• Device Sequence Number: 18271037
• Product Code: DQX
• UDI-Device Identifier: 10705032055031
• UDI-Public: 10705032055031
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K864058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2024

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: 07/31/2025
• Device Catalogue Number: 502455
• Device Lot Number: 35265205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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.; GUIDEWIRE.; SHEATH.
• Patient Sex: Unknown